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Category: AM-NC

  • MIL-OSI Europe: Briefing – Parliamentary confirmation hearings of the Commissioners-designate: An analysis of the portfolios of the new von der Leyen Commission – 17-10-2024

    Source: European Parliament

    This compendium brings together a set of briefings prepared by the European Parliamentary Research Service (EPRS) to guide Members of the European Parliament through the parliamentary hearings of Commissioners-designate in early November 2024. These public confirmation hearings form the backdrop to Parliament’s confirmation vote on the College of Commissioners put forward by Ursula von der Leyen, following her re-election as Commission President by the European Parliament in July 2024. In addition to an overview of the process, setting its historical and political context, this volume contains a briefing on each of the Commissioners-designate and their portfolios. Each of these briefings highlights some of the key issues and recent developments in the portfolio, as well as looking back on Parliament’s activity in the area in the last parliamentary term.

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0121/2024

    Source: European Parliament

    B10‑0121/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

    The European Parliament,

    – having regard to the Treaty on the Functioning of the European Union, in particular Article 168 thereof,

    – having regard to the Charter of Fundamental Rights of the European Union, in particular Article 35 thereof,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC[1] (MDR),

    – having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU[2] (IVDR),

    – having regard to Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions[3],

    – having regard to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices[4],

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas medical devices play a pivotal role in the healthcare industry, facilitating the diagnosis, prevention, monitoring and treatment of various medical conditions;

    B. whereas people rely on these devices every day and expect them to be safe, available and affordable;

    C. whereas after a series of scandals, in which patient safety was jeopardised for profits, including cases of leaking breast implants, the new MDR and IVDR were agreed;

    D. whereas these regulations updated the rules on the placing on the market of medical devices for human use and their accessories, as well as the rules for making such devices and accessories available on the market and putting them into service in the EU; whereas they also contain rules on how clinical investigations concerning such devices and accessories are carried out in the EU;

    E. whereas the main aim of the regulations is to improve patient safety by introducing more stringent procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance;

    F. whereas in 2020, amending Regulation (EU) 2020/561 was adopted to allow EU Member States and their authorities and institutions to prioritise the fight against the COVID-19 pandemic; whereas the application of certain of the MDR’s rules was deferred by one year to ensure the smooth functioning of the EU’s internal market, to maintain a high level of public health protection and patient safety, to provide legal certainty and to avoid potential market disruption during the pandemic;

    G. whereas in 2023, amending Regulation (EU) 2023/607 was adopted as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, permitting extensions where needed;

    H. whereas some of the manufacturers of medical devices remain persistently unprepared to meet the requirements of the regulations;

    I. whereas some of the notified bodies who carry out the assessment and certification of medical devices have created an unpredictable work environment for manufacturers of medical devices;

    J. whereas there is no clarity on any actual shortages of medical devices nor on risks posed by shortages for specific therapeutic areas; whereas more factual information is needed to properly address the situation;

    K. whereas the European Database on Medical Devices (EUDAMED) is an integral part of the MDR and the IVDR;

    1. Expresses its continued support for the strong and strict protection of patient health and safety, including through the correct implementation of the MDR and the IVDR; underlines that patient safety must never be compromised;

    2. Regrets possible shortages of medical devices and risks thereof, notably in the areas of paediatric care and orphan devices, resulting mainly from a suboptimal implementation of the legal framework;

    3. Points out that the President of the European Commission has tasked the Commissioner-designate for Health and Animal Welfare with ensuring ‘the availability and competitiveness of medical devices, including by stepping up the implementation of current framework and evaluating the need for potential legislative changes’;

    4. Welcomes the Commission’s ongoing non-legislative actions to support the transition to the new regulations, including advice and guidance on the clinical evidence needed for fee-free conformity assessment, training, coaching and internship activities for notified bodies and conformity assessment bodies, and support for the development of innovative and orphan devices;

    5. Stresses that the ongoing evaluation of the MDR and IVDR will generate much needed data and should be concluded and its results fully taken into account in any future revision of the MDR and IVDR, which should be accompanied by the customary full impact assessment;

    6. Underlines that citizens, including patients in particular, as well as governments, civil society organisations and manufacturers of medical devices, have a right to information on the processes used by notified bodies for the certification of medical devices, including information on the timelines and fees;

    7. Regrets the fact that notified bodies seem to have been misusing their critical position in the value chain, and points to the fact that this endangers patient safety and treatment options;

    8. Expects all manufacturers of medical devices to be able to meet the requirements of the MDR and IVDR without any further delay;

    9. Expects all notified bodies to ensure, through their work, that safe and reliable medical devices obtain timely and affordable access to the market, in a predictable and consistent manner;

    10. Calls on the Commission to step up its efforts to ensure that the notified bodies use common and transparent working methods; invites the Commission to explore the possibility of ensuring more harmonisation, transparency and predictability of the certification processes, timelines and fees of the notified bodies, by means of implementing or delegated acts;

    11. Calls on the Commission also to investigate ways to increase the transparency of the entire certification process conducted by notified bodies, to ensure that the public, civil society, academia and governments can scrutinise the work done; stresses that this would enhance the safety of the medical devices;

    12. Calls for the full implementation of EUDAMED in accordance with the agreed timeline;

    13. Underlines that any future legislative proposal on medical devices should be patient-centred and should put patient safety first;

    14. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

    MIL OSI Europe News –

  • MIL-OSI Europe: Press release – European Parliament Press Kit for the European Council of 17 and 18 October 2024

    Source: European Parliament

    European Parliament President Roberta Metsola will represent the European Parliament at the summit, where she will address the heads of state or government at 10.00 and hold a press conference after her speech.

    When: Press conference at around 11.00 on 17 October

    Where: European Council press room and via Parliament’s webstreaming or EbS.

    At their meeting in Brussels, heads of state or government will discuss how the EU can continue supporting Kyiv against Russian aggression, and the EU’s response to the latest events in the Middle East, where Israeli forces continue their attacks on Gaza and in Lebanon, while Iran has launched missiles against Israel. EU leaders will also focus on making the European economy more competitive, following the publication of Mario Draghi’s report, which calls for a boost in public investment and wide-ranging economic reforms. They will also discuss ways to manage migration flows and ensure border protection, climate change and biodiversity, and the situation in Georgia, Moldova, Venezuela and Sudan.

    Hamas terrorist attacks against Israel / Escalating violence in the Middle East

    President Metsola marked the one-year anniversary of terrorist attacks in Israel at the opening of the 7-10 October plenary session in Strasbourg. Recalling the horror of that day “that will live in infamy”, President Metsola said nothing could ever justify the indiscriminate mass murder, rape, kidnapping and torture that occurred one year ago. Since then, too few have been able to make it back to their loved ones – “this house will continue to do what we can to help bring them all home”, she said.

    The 7 October attacks triggered a cycle of war, death and devastation that has seen thousands killed in Gaza, and instability across the region, President Metsola stated. In remembering all those lost and taken, the President added that “Parliament’s calls for the immediate release of the remaining hostages will remain steadfast, our calls for ceasefire will remain resolute, and our efforts towards de-escalation will remain strong.” The work for real, dignified, long-term and sustainable peace will remain unwavering, she concluded. MEPs held a minute of silence in memory of all the innocent lives lost.

    In a resolution adopted on 25 April, MEPs strongly condemn the Iranian drone and missile attack on Israel and call for further sanctions against Iran. Parliament voices serious concern over the escalation and threat to regional security. MEPs reiterate their full support for the security of the State of Israel and its citizens and condemn the simultaneous rocket launches carried out by Iran’s proxies Hezbollah in Lebanon and Houthi rebels in Yemen against the Golan Heights and Israeli territory before and during the Iranian attack.

    At the same time, they deplore the attack on the Iranian consulate in the Syrian capital Damascus on 1 April, which is widely attributed to Israel. The resolution recalls the importance of the principle of the inviolability of diplomatic and consular premises, which must be respected in all cases under international law.

    Further reading

    Parliament marks one year from the October 7th attacks in Israel

    Parliament condemns Iran’s attack on Israel and calls for de-escalation

    Parliament calls on Israel to open all crossings to Gaza for humanitarian aid

    Israel-Hamas war: MEPs call for a permanent ceasefire under two conditions


    MEPs condemn Hamas attack on Israel and call for a humanitarian pause

    Resolution: The despicable terrorist attacks by Hamas against Israel, Israel’s right to defend itself in line with humanitarian and international law and the humanitarian situation in Gaza

    President Metsola at the European Council: EU must remain coherent and united

    Leading MEPs condemn attack by Hamas terrorists against Israel

    MEPs to contact

    David McALLISTER, (EPP, DE), Chair of the Committee on Foreign Affairs

    Marie-Agnes STRACK-ZIMMERMANN (Renew, DE), Chair of the Subcommittee on Security and Defence

    Russia’s war against Ukraine

    On 14 October, MEPs on the Trade Committee endorsed the Commission’s proposal to support Ukraine with an exceptional Macro-Financial Assistance (MFA) loan of up to €35 billion. This is the EU’s contribution under the G7’s initiative to support Ukraine with up to $50 billion (approximately €45 billion) to address Ukraine’s urgent financing needs in the face of Russia’s brutal war of aggression. The repayment of this exceptional MFA loan and of the loans from other G7 countries will come from the extraordinary revenues made from immobilised Russian Central Bank assets, and enabled by the Ukraine Loan Cooperation Mechanism, newly established under the Commission’s proposal. The plenary vote is scheduled during next week’s session in Strasbourg.

    In a resolution adopted on 19 September, MEPs want EU countries to lift current restrictions hindering Ukraine from using Western weapons systems against legitimate military targets in Russia. The text states that if current restrictions are not lifted, Ukraine cannot fully exercise its right to self-defence and remains exposed to attacks on its population and infrastructure. Parliament underlines that insufficient deliveries of ammunition and restrictions on their use risks offsetting the impact of efforts made to date, and deplores that EU countries are offering less bilateral military aid to Ukraine. MEPs reiterate their call for member states to fulfil their March 2023 commitment to deliver one million rounds of ammunition to Ukraine, and to accelerate the delivery of weapons, air defence systems and ammunition, including TAURUS missiles. They also restate their position that all EU countries and NATO allies should collectively and individually commit to annual military support for Ukraine of no less than 0.25% of their GDP.

    While calling on the EU and its member states to actively work towards achieving the broadest possible international support for Ukraine and identifying a peaceful solution to the war, MEPs say that any resolution must be based on full respect for Ukraine’s independence, sovereignty and territorial integrity. They also view holding Russia accountable for war crimes and reparations, and other payments by Moscow, as essential aspects of any solution. To this end, MEPs want the EU and like-minded partners to establish a sound legal regime to confiscate Russian state-owned assets frozen by the EU as part of efforts to compensate Ukraine for the massive damage it has suffered.

    With Russia’s war against Ukraine raging on, Parliament reconfirmed on 17 July its view that the EU must continue to support Kyiv for as long as it takes until victory. The resolution, which sets out the newly-elected European Parliament’s first official position on Russia’s war of aggression against Ukraine, restates MEPs’ continued support for Ukraine’s independence, sovereignty, and territorial integrity within its internationally recognised borders. It calls on the EU to maintain and extend its sanctions policy against Russia and Belarus, monitor and review its effectiveness and impact, and systematically tackle the issue of EU-based companies, third parties, and third countries that circumvent sanctions.

    Further reading

    Ukraine: Trade Committee endorses financial support backed by Russian assets

    MEPs: Ukraine must be able to strike legitimate military targets in Russia

    Newly elected Parliament reaffirms its strong support for Ukraine

    MEPs approve trade support measures for Ukraine with protection for EU farmers

    Joint Statement by the Presidents of the European Union Institutions on the occasion of the 2 year anniversary of the Russian invasion of Ukraine

    Parliament calls on the EU to give Ukraine whatever it needs to defeat Russia

    EU sanctions: new rules to crack down on violations

    MEPs: EU must actively support Russia’s democratic opposition

    Yulia Navalnaya: “If you want to defeat Putin, fight his criminal gang”

    Debate 12 March 2024: Preparation of the European Council meeting of 21 and 22 March 2024

    Debate 13 March 2024: Need to address the urgent concerns surrounding Ukrainian children forcibly deported to Russia

    Parliament wants tougher enforcement of EU sanctions against Russia

    A long-term solution for Ukraine’s funding needs

    How the EU is supporting Ukraine

    EU stands with Ukraine

    MEPs to contact

    David McALLISTER, (EPP, DE) Chair of the Committee on Foreign Affairs

    Marie-Agnes STRACK-ZIMMERMANN (Renew, DE), Chair of the Subcommittee on Security and Defence

    Karin KARLSBRO (Renew, SE), rapporteur on macro-financial assistance to Ukraine

    Competitiveness

    On 17 September, Mario Draghi outlined his blueprint for making Europe more competitive through closer cooperation in core areas and massive investment in shared objectives.

    Mr Draghi said that the EU needed to focus on three crucial issues: closing the innovation gap with the US and China; developing a joint plan to link the goal of decarbonisation with increased competitiveness; and boosting Europe’s security and reducing its dependence on foreign economic powers. A fit-for-purpose competitiveness agenda would require annual funding of between EUR 750 – EUR 800 billion for projects whose objectives were already agreed upon by the EU. Some of this money could come from private sources, but some would also need to be secured through public investment, including by new common debt issued specifically to fund key joint projects, Mr Draghi said.

    In a debate following Mr Draghi’s address, many MEPs agreed with his analysis that the EU economy must urgently change course. The EU should focus, they argued, on competition and innovation in key industries, along with more public and private investments in social, green and digital transformations. Some MEPs called for greater sovereignty and freer markets, and stressed that fighting climate change sabotages the EU economy. Others observed that growth is compatible with clean innovative technologies and social investment, to help citizens to learn new skills.

    Further reading

    Draghi to MEPs: “Europe faces a choice between exit, paralysis, or integration”

    MEPs adopt plans to boost Europe’s Net-Zero technology production

    New EU fiscal rules approved by MEPs

    MEPs to contact

    Borys Budka (EPP, PL), Chair Committee on Industry, Research and Energy

    Migration

    During a press point with the Estonian Prime Minister on 16 October, EP President Roberta Metsola stressed that it is “important that we implement the migration pact. We need to be fair with those eligible for protection, firm with those who are not, and harsh with smugglers and malign states like Belarus or Russia who seek to exploit those most vulnerable. Only a coordinated European approach can ensure the integrity of our borderless Schengen area.”

    On 9 October, Parliament debated how to strengthen the security of Europe’s external borders and the need for a comprehensive approach and enhanced Frontex support. You can watch the debate here. On 7 October, MEPs discussed the reintroduction of internal border controls in a number of member states and its impact on the Schengen Area. Watch the debate here.

    On 10 April, MEPs approved the new Migration and Asylum Pact. The package consists of ten legislative texts to reform the European migration and asylum policy and was agreed with EU member states. You can find the adopted texts here and watch the plenary debate here.

    Further reading

    MEPs approve the new Migration and Asylum Pact

    MEP to contact

    Javier ZARZALEJOS (EPP, ES), Chair of the Committee on Civil Liberties, Justice and Home Affairs

    Foreign affairs: Georgia, Moldova, Venezuela, Sudan

    In a resolution adopted on 9 October, MEPs say current democratic backsliding in Georgia effectively puts the country’s integration with the EU on hold. The text highlights how the ruling Georgian Dream party has pushed an increasingly authoritarian agenda, including on media freedom and LGBTQ+ rights. Coupled with changes to the country’s electoral legislation and growing anti-EU rhetoric, MEPs say these laws violate the freedom of expression, censor media, impose restrictions on critical voices in civil society and the NGO sector and discriminate against vulnerable people. They also make clear that unless the legislation is rescinded, progress cannot be made in Georgia’s relations with the EU.

    Against the backdrop of the continuing decline of Georgia’s democracy, Parliament demands that all EU funding provided to the Georgian government be frozen until the undemocratic laws are repealed. Any future funding of the Georgian government can only be disbursed under strict conditions, MEPs argue.

    On 9 October, MEPs adopted a resolution issuing a strong warning against continued Russian attempts to derail Moldova’s pro-European trajectory. The text vehemently condemns Russia’s escalating malicious activities, interference and hybrid operations ahead of Moldovans going to the polls to vote in the country’s presidential election and constitutional referendum on EU integration on 20 October. MEPs highlight the role played by a plethora of malicious actors, including pro-Russian Moldovan oligarchs and Russia’s state-funded RT network, in carrying out voter fraud schemes as well as cyber operations and information warfare. They also call on the EU and its member states to ensure that all necessary assistance is provided to Moldova to strengthen its institutional mechanisms and ability to respond to hybrid threats.

    The European Parliament reaffirms its support for Moldova’s path towards EU accession, calling on the European Commission to include the country in the Instrument for Pre-Accession Assistance (IPA III) and to prioritise funding for EU candidate countries in the next Multiannual Financial Framework (MFF) for 2028-2034. With EU accession talks with Moldova already having begun, MEPs call for a faster screening process and the timely organisation of the subsequent intergovernmental conferences.

    In a resolution adopted on 19 September, Parliament says the EU should do its utmost to ensure that Edmundo González Urrutia, the legitimate and democratically elected President of Venezuela, can take office on 10 January 2025. MEPs “strongly condemn and fully reject the electoral fraud orchestrated by the regime-controlled National Electoral Council, which refused to make public the official result.” They recognise Edmundo González Urrutia as the country’s legitimate and democratically elected president, and María Corina Machado as the leader of the democratic forces in Venezuela. They also strongly condemn the Venezuelan Government’s issuance of an arrest warrant for Mr González.

    On 8 October, MEPs held a plenary debate on the situation in Sudan. You can watch the debate here.

    Further reading

    Parliament says Georgia’s democracy is at risk

    Resolution: The democratic backsliding and threats to political pluralism in Georgia

    Parliament condemns Russia’s interference in Moldova

    Resolution: Strengthening Moldova’s resilience against Russian interference ahead of the upcoming presidential elections and a constitutional referendum on EU integration

    Venezuela: MEPs recognise Edmundo González as President

    Resolution: Situation in Venezuela

    MEPs to contact

    David McALLISTER, (EPP, DE) Chair of the Committee on Foreign Affairs

    Nils UŠAKOVS (S&D, LV), Chair of the Delegation to the EU-Armenia Parliamentary Partnership Committee, the EU-Azerbaijan Parliamentary Cooperation Committee and the EU-Georgia Parliamentary Association Committee

    Climate change and biodiversity

    A Parliament delegation will attend the UN Climate Change Conference (COP29) in Baku, Azerbaijan between 18 and 22 November 2024. MEPs will also adopt a resolution during the 13-14 November plenary session, which will constitute the delegation’s mandate for talks with international partners.

    Parliament will also send a delegation to the UN Biodiversity Conference (COP16) in Cali, Colombia, between 28 and 31 October 2024.

    MEPs to contact

    Lídia PEREIRA (EPP, PT), Chair of the delegation to the COP29 UN Climate Change Conference, Baku, Azerbaijan

    Antonio DECARO (S&D, IT), Chair of the Committee on the Environment, Public Health and Food Safety

    MIL OSI Europe News –

  • MIL-OSI Europe: At a Glance – Question time – Animal health: Preventing and preparing for future health crises in agriculture – 17-10-2024

    Source: European Parliament

    Animal diseases can result in heavy livestock losses and economic costs, and potentially threaten human health. Through the ‘One Health’ approach and the EU4Health programme, the European Commission wants to link animal, human and soil health, biodiversity, climate, sustainable use of pesticides, and disease surveillance and prevention, to ensure prompt action in future health emergencies. The topic is scheduled for question time with the Commission during the October II plenary session.

    MIL OSI Europe News –

  • MIL-OSI Europe: Press release – 2024 Sakharov Prize finalists shortlisted by MEPs

    Source: European Parliament

    Members of Parliament’s Foreign Affairs and Development committees have chosen the three finalists for the 2024 Sakharov Prize in a vote on Thursday.

    Following the secret ballot, MEPs selected the three finalists for the 2024 Sakharov Prize for Freedom of Thought. These are, in alphabetical order:

    – Dr Gubad Ibadoghlu, academic and anti-corruption activist in Azerbaijan;

    – María Corina Machado, as leader of the democratic forces in Venezuela and President-elect Edmundo González Urrutia, representing all Venezuelans inside and outside the country fighting to restore freedom and democracy;

    – “Women Wage Peace” and “Women of the Sun”, Israel/Palestine.

    Find the biographies of the candidates and finalists by following this link.

    Next steps

    The Conference of Presidents (EP President Roberta Metsola and the leaders of the political groups) will choose the 2024 laureate of the Sakharov Prize for Freedom of Thought on Thursday 24 October. The winner(s) will be announced immediately afterwards in the plenary session in Strasbourg.

    The award ceremony, which foresees an endowment of EUR 50 000 for the winner(s), will take place during the December plenary session in Strasbourg.

    Background

    Named after Soviet physicist and political dissident Andrei Sakharov, who agreed to his name being used, the Sakharov Prize for Freedom of Thought is the EU’s highest human rights award.

    It has been awarded by Parliament to individuals or organisations every year since 1988, in recognition of their work in one of the following areas: the defence of human rights and fundamental rights, in particular freedom of expression, the safeguarding of minority rights, respect for international law, the development of democracy and the defence of the rule of law.

    Many worthy winners have received the award, including Nelson Mandela and Anatoly Marchenko in the first edition, and also dissidents, political leaders, journalists, lawyers, civil society activists, the United Nations and a child activist for the right to education.

    Several Sakharov Prize laureates have also won the Nobel Peace Prize, such as Nelson Mandela, Malala Yousafzai, Denis Mukwege and Nadia Mourad.

    For a list of previous winners, click here.
    In 2023, the Sakharov Prize for Freedom of Thought was awarded to Jina Mahsa Amini and the ‘Woman, Life, Freedom’ movement in Iran.

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0127/2024

    Source: European Parliament

    B10‑0127/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

     

     

    The European Parliament,

    – having regard to Article 5(3) of the Treaty on European Union,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC[1] (the Medical Devices Regulation),

    – having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU[2] (the In Vitro Diagnostic Medical Devices Regulation),

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas public health is and should remain primarily a competence of the Member States;

    B. whereas the implementation of the Medical Devices Regulation has triggered many challenges for manufacturers, notified bodies and healthcare providers;

    C. whereas the current complex and costly regulatory framework jeopardises the availability and affordability of medical devices for patients;

    1. Calls on the Commission to propose a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to address the challenges that have emerged in their implementation;

    2. Underlines that the revision of these regulations should take into consideration the views of the stakeholders along the entire value chain;

    3. Stresses that this revision should focus on ensuring the timely availability of medical technologies, a more predictable regulatory system and a reduction in the administrative burden for manufacturers, especially small and medium-sized enterprises;

    4. Emphasises that this revision should also contribute to increasing the competitiveness of the sector, while ensuring a high level of patient safety;

    5. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

     

     

     

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0125/2024

    Source: European Parliament

    B10‑0125/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

    The European Parliament,

     – having regard to Article 168 of the Treaty on the Functioning of the European Union, which provides that ‘a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities’,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR)[1], and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR)[2],

    – having regard to the Commission’s 2023 implementation report on the MDR/IVDR[3],

    – having regard to the European Medicines Agency’s 2023 Annual Report and its review on market access and safety concerns for medical devices[4],

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas medical devices and in vitro diagnostic medical devices play a crucial role in modern healthcare, directly affecting the health, safety and well-being of millions of patients across the EU;

    B. whereas the introduction of the MDR and the IVDR was intended to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices, ensuring higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector;

    C. whereas despite these aims, significant challenges have been encountered in implementing the MDR and the IVDR, not only leading to delays but also resulting in failures to achieve certification and approval of medical devices and in vitro diagnostic medical devices, particularly impacting small- and medium-sized enterprises (SMEs), as well as resulting in shortages of medical devices and in vitro diagnostic medical devices, thus restricting patient access to innovative therapeutic and diagnostic technologies;

    D. whereas many stakeholders, especially including SMEs, notified bodies and healthcare providers, have reported difficulties in navigating the complex and costly regulatory procedures under the current MDR and IVDR framework, with potential risks posed to the continuous availability of life-saving medical devices and critical in vitro diagnostic tests in Europe as manufacturers reduce their product portfolios and withdraw from the EU;

    E. whereas recent scientific and market data point to concerns about shortages of capacity among notified bodies, leading to bottlenecks in the certification process, as well as a lack of clarity around the interpretation of several key provisions of the MDR and the IVDR;

    F. whereas the COVID-19 pandemic further exposed vulnerabilities in the EU’s supply chain for medical devices and in vitro diagnostic medical devices, highlighting the need for more flexible and efficient regulatory mechanisms to ensure timely access to essential devices during public health emergencies;

    G. whereas given the rapid pace of innovation, including advances in digital health, artificial intelligence and personalised medicine, there is an urgent need to revise the MDR and the IVDR in order to accommodate new technologies and ensure that the regulatory framework remains fit for purpose;

    H. whereas practical observations following the adoption of the MDR and the IVDR indicate that significant financial and administrative barriers for orphan and innovative devices stem from the complex procedures of conformity assessment, including obtaining scientific advice, fees required by notified bodies, the extensive and unpredictable duration of the conformity assessment process, and the associated costs;

    I. whereas the MDR and the IVDR also present challenges for maintaining equitable access to devices across all of the Member States, with patients in less economically developed regions facing additional delays in accessing new technologies;

    1. Calls on the Commission to put forward, in the first hundred days of the new mandate, a proposal for a systematic revision of Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR);

    2. Recognises the significant contributions of the MDR and the IVDR to enhancing the safety and quality of medical devices, but stresses the need for an urgent review of some of its provisions to address the delays and bottlenecks that are currently hampering access to medical technologies; underlines that the review must aim to make full use of the mechanisms in Article 36(3) MDR to adopt implementing acts in order to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency and reduce the bureaucratic burden by eliminating any unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising on patient safety;

    3. Stresses the importance of increasing the capacity of notified bodies in order to ensure the timely certification of medical devices and in vitro diagnostic medical devices; urges the Member States and the Commission to implement measures that significantly increase the speed and efficiency of these bodies in order to address the critical demand in the medical device sector;

    4. Advocates for the abolition of re-certification for lower-risk products, including Class IIa and certain Class IIb devices, which should continue to be valid subject to appropriate surveillance by the notified body;

    5. Asks the Commission also to consider the abolition of re-certification for implantable devices in Class IIb and devices in Class III, provided ongoing compliance with post-market surveillance and periodic safety update reports demonstrate that the devices perform as intended;

    6. Asks the Commission also to consider the abolition of repeated re-certification for in-vitro diagnostic medical devices after an initial re-certification after five years, subject to appropriate surveillance by the notified body;

    7. Advocates for the creation of transparent, harmonised, maximum durations for procedural steps in conformity assessments by notified bodies, which would create legal certainty for manufacturers regarding the market access procedure and its duration within the EU;

    8. Demands the transparency and EU-wide harmonisation of notified bodies’ fees and fee structures, published in a standardised EU dashboard to allow economic operators to compare notified bodies and make informed choices, ensuring that fees remain a fair compensation for the public service provided;

    9. Calls for a revision of the qualification criteria for persons responsible for regulatory compliance (PRRCs) in the MDR and the IVDR; recommends that the criteria be changed to allow practical experience and training as an alternative to academic qualifications, thereby ensuring that a broader range of competencies are considered for the qualification of PRRCs;

    10. Calls for the regulatory adaptation of the MDR and the IVDR to accommodate new technologies; recognises that the current framework of the MDR and the IVDR does not fully accommodate rapid advancements in medical technology, especially in fields such as digital health, AI-driven diagnostics and personalised medical devices; calls for amendments to the MDR and the IVDR to establish clear and fast-track pathways for the approval of innovative technologies, ensuring their safety and performance; proposes the introduction of a prioritisation procedure for innovative medical devices and in vitro diagnostic medical devices, including a fast-track approval process for breakthrough devices that are potentially life-saving or otherwise significantly improve the standard of care;

    11. Calls for clear definitions of ‘orphan device,’ ‘orphan population’ and ‘orphan subpopulation’, as determined by the Medical Device Coordination Group in the MDR and the IVDR, to be given in order to provide legal clarity and facilitate the adoption of harmonised measures across the EU, thereby ensuring a high level of safety, quality and transparency in the granting of market access to critical medical devices and in vitro diagnostic medical devices;

    12. Calls for the introduction of simplified rules for niche market (and orphan) medical devices analogous to those in other jurisdictions, such as the US; emphasises the need for less burdensome conformity assessment procedures tailored to medical devices and in vitro diagnostic medical devices serving relatively small markets, such as products for the treatment of children or rare diseases;

    13. Urges the creation of a register to monitor and ensure the safety and efficacy of these niche and orphan devices; suggests, further, the creation of EU-wide clinical registries, or the amalgamation of data from current national registries, in order to gather comprehensive clinical data on small patient groups that benefit from the availability of orphan devices; notes that this initiative aims to enhance the overall quality of care and support manufacturers in collecting necessary clinical data, especially in indications where multiple orphan devices are available, allowing for combined treatment data to be evaluated and published regularly; observes that the goal is to assure maximum transparency and safety while allowing a streamlined and less bureaucratic approach for niche and orphan devices;

    14. Recognises the disproportionate regulatory burden faced by SMEs, which are responsible for the majority of products in the medical device and in vitro diagnostic medical device sector; highlights that this burden threatens to stifle innovation and reduce competition; urges the Commission to develop specific measures to support SMEs, including the provision of model application documents and forms, financial assistance, regulatory guidance and tailored certification pathways that reduce costs and complexity while maintaining high standards of patient safety; proposes the reduction of conformity assessment costs for SMEs by implementing specific provisions such as a reduction in fees, deferral of the payment of fees and provision of administrative assistance through a central EU contact point;

    15. Calls for enhanced flexibility in the regulatory process during public health emergencies; stresses the need for a dynamic regulatory framework capable of a rapid response to public health crises, such as pandemics or unforeseen emergencies; urges the Commission to establish emergency provisions that allow for the temporary streamlining of certification processes for critical medical devices, ensuring that such adjustments do not compromise safety standards, thereby facilitating timely access to essential devices during times of crisis; calls for the Commission, in cooperation with the Health Emergency Preparedness and Response structure, to establish a non-exhaustive list of critical medical devices;

    16. Calls for the establishment of a central governance structure or medical device office within the Commission’s Directorate-General for Health to centralise responsibilities and powers in the designation management and surveillance of notified bodies, the harmonisation of administrative practices, the development of guidance on the implementation and application of EU regulations applicable to medical devices and in vitro diagnostic medical devices, and the coordination of the applicability of other EU regulations to medical devices and in vitro diagnostic medical devices with other directorates-general of the Commission;

    17. Calls for a stronger and more harmonised post-market surveillance system that makes use of real-world data and patient feedback to identify and address safety issues more rapidly; encourages, therefore, the establishment of a centralised EU database for post-market data as part of the module for vigilance and post-market surveillance of the European Database on Medical Devices that ensures transparency and facilitates cross-border cooperation in monitoring device performance and addressing risks;

    18. Calls on the Member States to inform the central governance structure or office of the results of notified body audits and specific instructions issued to notified bodies concerning administrative practices and conformity assessment procedures; highlights the need for this central governance structure or office to coordinate Member States’ market surveillance and vigilance activities in order to enhance the efficiency of market surveillance across the EU;

    19. Urges the Commission to strengthen international cooperation on the simplification, assimilation and mutual recognition of national certification processes, in particular with the US Food and Drug Administration;

    20. Calls for an appropriate transition period before the implementation of new rules; emphasises the need to set a transition period before the enforcement of new regulations that would allow enough time for manufacturers to prepare and for the necessary institutional infrastructure to be established; notes that this measure ensures that all stakeholders are fully equipped to meet the regulatory requirements without compromising the overarching objectives of the legislation;

    21. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

     

     

     

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0124/2024

    Source: European Parliament

    B10‑0124/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

    The European Parliament,

    – having regard to the Treaty on the Functioning of the European Union, in particular Article 168 thereof,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC[1] (the Medical Devices Regulation – MDR),

    – having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU[2] (the In Vitro Diagnostic Medical Devices Regulation – IVDR),

    – having regard to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices[3],

    – having regard to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices[4],

    – having regard to the Commission’s 2023 report on the implementation of the MDR and the IVDR,

    – having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment[5],

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas access to quality medical devices and in vitro medical devices is indispensable for patients’ health and for healthcare systems;

    B. whereas more than 500 000 different medical devices are marketed in the EU, covering a broad range of products from plasters to x-ray machines, and they are used for diagnosis, prevention, treatment and rehabilitation and, overall, to improve the quality of life of patients and the work of healthcare professionals and carers;

    C. whereas large differences still remain in access to medical devices across the EU, leading to healthcare inequalities;

    D. whereas the MDR and the IVDR were adopted to strengthen the regulatory framework in response to several scandals involving the use of unsafe medical equipment, such as hip and breast implants; whereas patient safety and quality standards should never be compromised;

    E. whereas the deadlines set in the MDR and the IVDR have been extended several times to give more time to device developers and notified bodies, and to avoid shortages of devices;

    F. whereas despite these deadline extensions, healthcare professionals have reported shortages of medical devices and in vitro medical devices, especially for paediatric and orphan devices;

    G. whereas it is still uncertain exactly which medical devices are at risk of withdrawal and shortages, because of a lack of transparency from notified bodies;

    H. whereas the majority of developers of medical devices and in vitro medical devices are small and medium-sized enterprises with limited resources;

    I. whereas the process of applying for certification can be burdensome, lengthy and expensive, especially in some Member States;

    J. whereas many stakeholders, such as developers, patient organisations and healthcare providers, have reported difficulties in navigating the regulatory framework for medical and in vitro medical devices;

    K. whereas increasing numbers of medical devices are supplied by producers in non-EU countries, some of which are autocratic regimes, raising concerns about the protection and possible misuse of personal medical data collected by medical devices;

    1. Deplores the shortages of medical devices and the lack of access to certain medical devices in parts of the EU; stresses that access to and quality of healthcare, including medical devices, should not depend on where in the EU a patient is located;

    2. Welcomes the increased capacity of notified bodies; invites the Member States and the Commission to assess whether measures can be taken to further improve the speed and efficiency of these notified bodies without jeopardising patient safety;

    3. Stresses the need for more transparency, information and guidance from the authorising authorities to manufacturers undergoing the certification process, including information regarding notified body fees and fee structures; underlines that this is already possible under the current regulation;

    4. Further stresses the need for greater transparency and better access to information for patients organisations and healthcare professionals from notified bodies and from national authorities;

    5. Underlines that product updates or adjustments should not necessarily lead to the need for a full recertification of the product; calls, in this regard, for harmonised guidance to ensure consistency for medical device developers across the EU;

    6. Welcomes the non-legislative actions already initiated by the Commission and calls for further actions to be taken to counter shortages and reduce the administrative burdens, where possible;

    7. Welcomes the pilot programme by the European Medicines Agency to support manufacturers producing and notified bodies certifying orphan devices in the processes of development and assessment;

    8. Notes that post-authorisation market surveillance can be burdensome, and that a more harmonised approach could benefit both developers and the Member States;

    9. Recalls that the MDR should be evaluated by 2027 at the latest; stresses, in this regard, the need for a proper evaluation and impact assessment; further stresses that all relevant stakeholders should be part of the evaluation process;

    10. Believes that reducing administrative burdens and ensuring access to medical devices throughout the EU should be key considerations in the evaluation of the regulation;

    11. Believes that the evaluation should also examine dependency on non-EU countries, including the protection of personal medical data;

    12. Emphasises that any new rules or changes to existing rules must come with an appropriate transition period to allow all stakeholders sufficient time to adjust to change;

    13. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

     

     

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0122/2024

    Source: European Parliament

    B10‑0122/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

    The European Parliament,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC[1] (Medical Devices Regulation, MDR), and to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU[2] (IVDR),

    – having regard to the Commission statement of 9 October 2024 on the urgent need to revise the Medical Devices Regulation,

    – having regard to the proposal for rejection of the Recommendation for second reading on in vitro diagnostic medical devices[3],

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas the legislation on medical devices and in vitro medical devices was revised in 2017 through the MDR and the IVDR;

    B. whereas the new legislative framework of 2017, which replaced the existing directives with regulations, was a reaction to certain events, first and foremost to a company’s marketing non-medical grade silicone gel breast implants in blatant and intentional violation of the regulatory framework; whereas there have been various violations under the new regulatory framework during the so-called pandemic;

    C. whereas the regulations have placed a considerable regulatory burden on the producers of medical devices and in vitro medical devices; whereas the MDR and the IVDR have created a considerable administrative burden for regulators; whereas the combined burden has created both a backlog of required certifications within the industry and an administrative bottleneck for issuing such certifications;

    D. whereas this backlog has affected the market for medical devices and in vitro medical devices; whereas there is a shortage of certain medical devices and in vitro medical devices; whereas producers’ innovative capacity has been impaired;

    E. whereas a prolonged waiting time for such products, shortages and a lack of innovation due to the inability to cope with bureaucratic obstacles harms patients as consumers of medical products; whereas such harm could ultimately result in an unnecessary loss of life;

    F. whereas the Commission needs to have finalised an evaluation of the directives by 27 May 2027 under Article 121 MDR and Article 111 IVDR;

    1. Considers that both the IVDR and the MDR have created very burdensome bureaucracy, which is neither in the interest of the producers nor in the interest of patients as consumers; suggests that any inappropriate or disproportionate regulatory burden be lifted as soon as possible; underlines that there is now an urgent need for revision of both the IVDR and the MDR;

    2. Recalls that as far back as in 2017 a Parliament minority moved to reject the new framework as too excessive a regulatory burden and too expensive for producers of medical devices to comply with; considers that law is good law when it can stand the test of time; recalls that perceived legislative necessity, as so often encountered in real or perceived crises, should not trump the established rules of proper lawmaking to the detriment of the smooth functioning of parliamentary democracy;

    3. Notes that proposals have been made to remedy the problems through tertiary legislation, thereby circumventing the ordinary legislative procedure; underlines that the shortcomings of Union secondary legislation cannot be corrected by tertiary-level legislation, as this would ultimately mean substituting Parliament’s lawmaking capacity with executive decrees; warns against the widespread and excessive use of delegated acts as a means of repairing flawed legislation;

    4. Calls on the Commission not to make use of the full time frame granted for evaluation of the IVDR and the MDR, but instead to speed up the process as much as possible; notes that the Commission has been called upon to come up with a proposal within a hundred days of the start of the new Commissioners’ term of office;

    5. Calls on the Commission to immediately present an amendment to address the glaring shortcomings of current legislation in the first half of 2025, so that businesses, patients as consumers and healthcare authorities can enjoy immediate relief; calls on the Commission to conduct its evaluation, and present a full legislative proposal, as swiftly as possible;

    6. Suggests including in its proposal an accelerated certification procedure for innovative medical products, abolishing the re-certification requirement for lower-risk products and abolishing the certification requirement for niche-products;

    7. Considers that, as a prerequisite, there is already a strong and functioning civil liability regime in place that protects consumers, allowing certain regulatory requirements to be relaxed;

    8. Instructs its President to forward this resolution to the Council, the Commission and the national parliaments of the Member States.

     

     

    MIL OSI Europe News –

  • MIL-OSI Europe: MOTION FOR A RESOLUTION on the urgent need to revise the Medical Devices Regulation – B10-0126/2024

    Source: European Parliament

    B10‑0126/2024

    European Parliament resolution on the urgent need to revise the Medical Devices Regulation

    (2024/2849(RSP))

    The European Parliament,

    – having regard to the Treaty on the Functioning of the European Union, in particular Article 168 thereof,

    – having regard to the Charter of Fundamental Rights of the European Union, in particular Article 35 thereof,

    – having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 15 December 2021 on medical devices[1] (Medical Devices Regulation),

    – having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices[2] (In Vitro Medical Devices Regulation),

    – having regard to Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions[3],

    – having regard to Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices[4],

    – having regard to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices[5],

    – having regard to Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices[6],

    – having regard to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices[7],

    – having regard to Rule 136(2) of its Rules of Procedure,

    A. whereas access to safe and effective medical devices and in vitro medical devices plays a crucial role in providing high quality treatment and care for patients in the EU;

    B. whereas approximately 500 000 different medical devices are available on the EU market, covering a broad range of technologies from contact lenses to pacemakers and serving different purposes, including diagnosis, prevention, treatment, rehabilitation, and improving the quality of life of patients[8];

    C. whereas the Medical Devices Regulation (MDR) and the In Vitro Medical Devices Regulation (IVDR) were adopted to strengthen the legal framework and enhance patient safety in response to a number of scandals involving unsafe medical equipment, such as hip- and breast implants, and to reduce the number of obsolete medical devices on the market;

    D. whereas incomplete applications with which manufacturers have not provided notified bodies with sufficient scientific evidence and technical detail are among the main reasons for the current delays in issuing CE certificates[9];

    E. whereas the implementation deadlines set in the MDR and IVDR were extended several times to increase the capacity of notified bodies and to help the industry to adjust to the new rules in order to avoid shortages of medical devices;

    F. whereas the Commission initiated non-legislative actions to support the transition to the MDR and IVDR, focusing in particular on the availability of medical devices on the market, the preparedness of notified bodies, the development of orphan and paediatric devices, SME support and free scientific advice;

    G. whereas although there is now an optimal number of notified bodies established under the MDR, issues remain in terms of the inconsistency of decisions, the lack of transparency regarding decisions and limited capacity for post-market surveillance; whereas more notified bodies still need to be established under the IVDR and the consistency and transparency of their decisions enhanced;

    H. whereas there is no harmonised mechanism to monitor interruption of supply of devices and whereas the limited requirement for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or in vitro medical devices was only introduced with Regulation (EU) 2024/1860 and will only take effect in January 2025; whereas to ensure patient health protection more transparency provisions linked to supply chain stability are needed so as to understand what types of devices are at serious risk of market withdrawals and shortages;

    1. Stresses its continued support for the swift implementation of the MDR and IVDR and underlines that patient safety must never be compromised and that equal access to quality medical devices must be ensured throughout the EU;

    2. Regrets the continuing risks of device shortages, notably in the areas of paediatric and orphan diseases, as a result of the suboptimal implementation of the legal framework;

    3. Stresses the urgent need for medical device supply chains to be transparent to prevent device shortages and the need for closer cooperation and stricter reporting obligations, including through the Medical Devices Coordination Group (MDCG) and the Executive Steering Group on Shortages of Medical Devices;

    4. Underlines that all relevant information on the processes and decisions of notified bodies regarding the certification of medical devices must be in the public domain and accessible to all the relevant stakeholders; in this regard, reiterates the need for a swift roll-out of a comprehensive, fully functional, and user-friendly European database for medical devices (EUDAMED) that provides complete information on all medical devices available on the EU market and adheres to the highest standards of transparency and accessibility of information;

    5. Welcomes the fact that the capacity of notified bodies has significantly increased in recent months and urges the Member States and the Commission to ensure a coordinated approach and harmonisation to improve the efficiency and predictability of decisions taken by notified bodies as well as their fee structure;

    6. Calls on the Commission to propose specific timeframes for conformity assessments linked to different classes of medical devices, to ensure predictability for developers, and to envisage the possibility of accelerated timelines when devices are linked to health emergencies or where there is robust scientific evidence of an extraordinary benefit for patients in areas of high unmet medical need;

    7. Reiterates that any incentives related to orphan medical devices must be based on clear eligibility criteria, be linked to a prudent system that prevents misuse through an artificial ‘orphanisation’ of the devices, and their use must be registered centrally to ensure better evidence generation throughout the EU;

    8. Underlines the need for more optimal stakeholder involvement, including within the notified bodies, and calls on the Member States and Commission to ensure that patients and healthcare professionals have access to all relevant documents and decisions;

    9. Underlines that product updates or adjustments should not necessarily lead to a need for an entire re-certification of the product, and in this regard calls for tertiary legislation to harmonise such provisions and ensure consistency for developers across the EU;

    10. Calls on manufacturers of medical devices to coordinate more closely with national authorities and prioritise patient safety by ensuring the generation of robust evidence and meeting the requirements of the MDR and IVDR without further delay;

    11. Welcomes the non-legislative actions already initiated by the Commission and urges more activities particularly vis-à-vis transparency and post-market surveillance; calls on the national competent authorities to significantly strengthen post-market surveillance activities and communication to patient organisations and healthcare professionals and the general public on risks to health or safety associated with marketed devices; calls on the authorities to ensure that manufacturers adhere to strict, clearly established timelines for implementing corrective actions, including prompt communication and follow-up with all potentially affected patients;

    12. Reiterates the need for a thorough evaluation and impact assessment of the MDR and IVDR before the potential reopening of the regulations and underlines that all the relevant stakeholders, including patients and healthcare professionals, must be involved in the evaluation process;

    13. Underlines that any potential revision of the medical devices framework must first and foremost uphold high patient safety standards, be based on evidence collected in the evaluation and impact assessment and ensure accompanying measures to support the transition;

    14. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

     

     

    MIL OSI Europe News –

  • MIL-OSI Asia-Pac: TONGA’S REAFFIRM ITS COMMITMENT AND UNWAVERING FAITH ON RENEWABLE ENERGY

    Source: Tonga Government

    Figure 1: Guest of Honours; Crown Prince Tupouto’a (fourth from left), Crown Princess Sinaitakala Tuku’aho (third from left), Princess Halaevalu (front row), Development Partners and the rest of the delegation during the Commissioning the Solar Powered Mini-grid

    Niuafo’ou, Tonga 11th October, 2024 – Crown Prince Tupouto’a ‘Ulukalala, Crown Princess Sinaitakala Tuku’aho and Princess Halaevalu commissioned the Solar Mini-grid system of Niuafo’ou. Minister of MEIDECC, Hon Fekita ‘Utoikamanu, HE Brek Batley, senior delegations from ADB, Tonga Power Limited, MEIDECC and the Prime Minister’s Office accompanied the guests of honor at the commissioning.

    Enthusiasm in the eyes of individuals who are granted the opportunity to enhance their access to electricity from limited hours each day to 24 hours per day, seven days a week was a was a significant milestone observed during the Commissioning of the solar mini-grid. The people of Niuafo’ou now have access to 24/7 electricity service generated from Renewable Energy.

    “I wish to reaffirm the Government’s commitment and Tonga’s unwavering faith on renewable energy as a key to addressing the single greatest threat to small island developing states – climate change”, said the Honourable Minister during the Commissioning.

    This is one of the Government’s ongoing efforts to improve quality and reliability of electricity supply that is generated from renewable energy. It is not just a technical shift from fossil fuels to renewable sources; it is a transformation that touches upon every aspect of Tongan lives especially in such remote communities like Niuafo’ou.

    The solar mini-grid was funded under the Tonga Renewable Energy Project (TREP) which was made possible through the kind assistance of the Green Climate Fund (GCF), Asian Development Bank (ADB), Australian Aid, and the Government of Tonga with the support of Tonga Power Limited  and the extraordinary efforts of the Principal Contractor, Infratec NZ and its sub-contractors during the installation stage.

    Tungua and Moungaone are in progress for the Haapai Islands and the 4 islands in Vavau (Hunga, Otea, Falevai, and Ofu) under the same project.

    MIL OSI Asia Pacific News –

  • MIL-OSI Asia-Pac: Special Campaign 4.0: Department of School Education & Literacy leads the way in cleanliness and sustainability

    Source: Government of India (2)

    Posted On: 16 OCT 2024 9:30PM by PIB Delhi

    Department of School Education & Literacy (DoSE&L), Ministry of Education along with its Autonomous Bodies (ABs) is actively engaged in the on-going Special Campaign 4.0 started from 2nd October 2024. DOSE&L has issued guidelines to all ABs for effective execution of Special Campaign 4.0. The focus is on cleanliness drives, managing scrap and pending matters, optimizing space and enhancing office aesthetics. These efforts emphasize efficiency, transparency and improved waste management in government functioning.

    At the start of the Special Campaign 4.0 preparatory phase, the Department of School Education & Literacy established specific targets and identified key cleanliness sites nationwide to ensure the effective implementation of the campaign’s goals.

    S.No.

    Category

    Targets

    1

    Number of Files to be Reviewed

    61100

    2

    Number of Files Identified for weeding out

    21410

    3

    Number of e-Files for Review

    1367

    4

    Number of Cleanliness Campaigns to be conducted

    32037

     

    Regular meetings are being conducted to closely monitor the progress towards achieving the Ministry’s set targets, ensuring effective implementation and timely completion of the campaign’s objectives. The targets finalized and action in progress as on 14.10.2024 on various parameters is as below:

    • As of now, 61,382 square feet of space has been reclaimed through the disposal of scrap and redundant materials, generating a revenue of Rs 7,34,941.
    • Out of 61,100 physical files identified for review, 48206 have been examined. So far, 22,135 files have been marked for weeding, with 10,883 already weeded out.
    • 27450 cleanliness campaigns have been conducted across schools and institutions, actively working towards achieving the Ministry’s targets.

    During Special Campaign 4.0, the enthusiastic participation of institutions and schools is setting a powerful example, driving the message of Swachhata forward with inspiration. National Bal Bhawan, through its vibrant exhibits and 3D models at the Swachhta Gallery, is actively engaging children and raising awareness about the importance of sanitation and hygiene, empowering them to take action in keeping their surroundings clean.

    Kendriya Vidyalaya schools across the borders, for example, KVS Kathmandu, KVS Moscow etc. are encouraged to adopt sustainable habits, aligning with the broader goals of Swachh Bharat Mission.”Ek Ped Maa Ke Naam” Campaign is being undertaken with great enthusiasm, with active participation of students, teachers, and community members. So far, under Special Campaign 4.0, a total of 8910 saplings have been planted, symbolizing a collective commitment to both cleanliness and environmental sustainability.

    *****

    MV/AK

    (Release ID: 2065624) Visitor Counter : 39

    MIL OSI Asia Pacific News –

  • MIL-OSI United Kingdom: Fostering is Everything

    Source: City of Derby

    Foster East Midlands, in partnership with CAN Media, is proud to present ‘Everything’ – a powerful new fostering film that highlights how fostering can truly mean everything to those involved. This film was created in collaboration with over 100 local authorities, including Derby City, Derbyshire County Council, Nottingham City, and Nottinghamshire County Council.

    ‘Everything’ follows foster carer Mike and his family on a journey through time with two of the children they have looked after, who are now adults. A surprise 60th birthday party for Mike gives Will and Zara a chance to reflect on how being fostered made a difference to their lives, thanking him for everything.

    Thanks to footage shot on a genuine old camcorder, we are taken to the 1990s, to see how Will settles into the family. We also jump back to the 2010s, when a young Zara is being taught to play the guitar by Mike, something that comes full circle when she performs a song at the party. Mike’s son Chris is involved throughout, showing the important role the children of foster carers play.

    All of the house and garden scenes were filmed in Chilwell, Nottinghamshire, adding a local and authentic touch to the film.

    The concluding message of the film is that what you do with your life could forever change someone else’s – encouraging people to foster in order to make that change.

    The film was developed with the input and insight of foster carers and people with care experience, was produced by Reel TwentyFive and project managed by public sector media partner CAN.

    Project Director for CAN Media, Rachel Brown describes the main message of the film:

    Many people don’t realise how common it is for relationships made through fostering to last well beyond the ‘official’ caring role. This has a huge impact on the lives of those who have been fostered, giving them stability and security well into adulthood.

    We also wanted to reflect how the children of foster carers make a difference to children when they come into care, helping them to feel part of the family.

    Having over 100 councils taking part in the project, the film will reach a very wide audience, encouraging people to find out more and take the steps towards becoming a foster carer.

    Fostering with your local council or children’s trust means you can better support local children and young people who need a safe and nurturing home where they can grow and thrive.

    Cllr Paul Hezelgrave, Lead Council’s Cabinet Member for Foster East Midlands said:

    The ‘Everything’ project has given our fostering service an amazing film that shows the long-term impact fostering can have, with relationships between carers and children lasting well into adulthood.

    All councils need to recruit more foster carers, and by collaborating to produce this emotionally powerful film, we will show people how rewarding and life-changing fostering is.

    The message is the same for all of us – we need more people to step forward and become foster carers. ‘Everything’ will help us to reach more people in our communities and encourage them to find out more about this really rewarding role.

    We are committed to giving vulnerable children and young people we care for the best chance to thrive, which for many of them is with local fostering families.

    Sarah Thomas, chief executive of the Fostering Network says:

    The Fostering Network has been proud to support the collaborative film projects since ‘Giants’ in 2017. It’s great to see local authority fostering services pooling resources to produce another amazing film. ‘Everything’ will help to amplify their message about the chronic shortage of fostering households, encouraging more people to come forward and foster.

    One of the main characters in the film, Chris, shows how important other family members are when it comes to fostering. This is something we champion throughout October, which is Children of Foster Carers Month.

    ‘Everything’ is the latest in a series of film collaborations that started in 2017 with ‘Giants’, which was supported by a small number of local authorities in the midlands and has now grown into a national project across England, reflecting the need to recruit more foster carers.

    Watch the full version of the ‘Everything’ Film on Foster for East Midlands YouTube channel or view the 30 second shortened version. 

    If you’re interested in becoming a foster carer or want to learn more, visit Foster for East Midlands webpage, email hello@fosterforeastmidlands.org.uk or call 03033 132950

    Be inspired and watch the ‘Everything’ foster film 

    MIL OSI United Kingdom –

  • MIL-OSI Asia-Pac: DARPG Secretary visits Department of Drinking Water and Sanitation, Ministry of Jal Shakti to review SPECIAL CAMPAIGN 4.0

    Source: Government of India

    Posted On: 17 OCT 2024 10:23AM by PIB Delhi

    Special Campaign 4.0 has been launched by Department of Administrative Reforms & Public Grievances (DARPG) for institutionalising Swachhata and minimising pendency in Government offices from 2nd October to 31st October, 2024. Department of Drinking Water and Sanitation, along with its Programme Divisions and Dr. Syama Prasad Mookerjee National Institute of Water and Sanitation (SPM-NIWAS) is actively participating in the Special Campaign for Disposal of Pending Matters (SCDPM) 4.0.

    Shri V. Srinivas, Secretary, DARPG had fruitful discussion with Ms. Vini Mahajan, Secretary, DDWS during his visit to Pt. Deendayal Antyodaya Bhawan, CGO Complex on 15.10.2024 at 4.30 PM with respect to review of Special Campaign 4.0.  Shri Ashok K. K. Meena, OSD, DDWS was also present along with senior officers from both the Departments. Secretary, DARPG also visited the creche in the Pt. Deendayal Antyodaya Bhawan, maintained by DDWS.

    Sharing the experience of “Swachhta Hi Sewa 2024”, Campaign, many valuable suggestions were made by Ms. Vini Mahajan, Secretary, DDWS with regard to Special Campaign 4.0 which inter-alia include extension of the Special Campaign beyond Central Govt offices; development of I-GoT module on Swachhta for all sanitation workers; Pension module for all those retiring in the near future; citizen friendly practices in ease of rules and procedures including their accessibility; inclusive measures like setting up of Creche facility; recognizing the efforts of the sanitation workers and honoring them,  holding special medical camps for them.

    ***

    DSK

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    MIL OSI Asia Pacific News –

  • MIL-OSI Asia-Pac: Special Campaign 4.0: Department of School Education & Literacy leads the way in cleanliness and sustainability

    Source: Government of India (2)

    Posted On: 16 OCT 2024 9:30PM by PIB Delhi

    Department of School Education & Literacy (DoSE&L), Ministry of Education along with its Autonomous Bodies (ABs) is actively engaged in the on-going Special Campaign 4.0 started from 2nd October 2024. DOSE&L has issued guidelines to all ABs for effective execution of Special Campaign 4.0. The focus is on cleanliness drives, managing scrap and pending matters, optimizing space and enhancing office aesthetics. These efforts emphasize efficiency, transparency and improved waste management in government functioning.

    At the start of the Special Campaign 4.0 preparatory phase, the Department of School Education & Literacy established specific targets and identified key cleanliness sites nationwide to ensure the effective implementation of the campaign’s goals.

    S.No.

    Category

    Targets

    1

    Number of Files to be Reviewed

    61100

    2

    Number of Files Identified for weeding out

    21410

    3

    Number of e-Files for Review

    1367

    4

    Number of Cleanliness Campaigns to be conducted

    32037

     

    Regular meetings are being conducted to closely monitor the progress towards achieving the Ministry’s set targets, ensuring effective implementation and timely completion of the campaign’s objectives. The targets finalized and action in progress as on 14.10.2024 on various parameters is as below:

    • As of now, 61,382 square feet of space has been reclaimed through the disposal of scrap and redundant materials, generating a revenue of Rs 7,34,941.
    • Out of 61,100 physical files identified for review, 48206 have been examined. So far, 22,135 files have been marked for weeding, with 10,883 already weeded out.
    • 27450 cleanliness campaigns have been conducted across schools and institutions, actively working towards achieving the Ministry’s targets.

    During Special Campaign 4.0, the enthusiastic participation of institutions and schools is setting a powerful example, driving the message of Swachhata forward with inspiration. National Bal Bhawan, through its vibrant exhibits and 3D models at the Swachhta Gallery, is actively engaging children and raising awareness about the importance of sanitation and hygiene, empowering them to take action in keeping their surroundings clean.

    Kendriya Vidyalaya schools across the borders, for example, KVS Kathmandu, KVS Moscow etc. are encouraged to adopt sustainable habits, aligning with the broader goals of Swachh Bharat Mission.”Ek Ped Maa Ke Naam” Campaign is being undertaken with great enthusiasm, with active participation of students, teachers, and community members. So far, under Special Campaign 4.0, a total of 8910 saplings have been planted, symbolizing a collective commitment to both cleanliness and environmental sustainability.

    *****

    MV/AK

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    MIL OSI Asia Pacific News –

  • MIL-OSI United Kingdom: Environment Agency works to preserve North East salmon stocks

    Source: United Kingdom – Executive Government & Departments

    Atlantic salmon stocks in the Tyne remain buoyant despite stocks across England reaching new lows according to a report released last week (Monday 7 October).

    An image of an adult salmon.

    Atlantic salmon stocks in the Tyne remain buoyant despite stocks across England reaching new lows according to a report released last week (Monday 7 October).  

    According to the Atlantic Salmon Stock Assessment for 2024 from the Environment Agency and the Centre for Environment, Fisheries and Aquaculture Science (Cefas), 90% of principal salmon rivers in England are classified as either “at risk” or “probably at risk,” meaning salmon numbers are below minimum levels to support sustainable populations.

    However, the River Tyne’s salmon stocks are the only location where they remain “not at risk” and the Coquet and Wear are amongst only three rivers nationally where stocks are deemed to be “probably not at risk”.

    The Environment Agency is working with partners to reduce impacts affecting stocks globally, including barriers to migration, water scarcity from abstraction and the persistent challenge from climate change, including warming seas.

    The Environment Agency and Natural England are calling on everyone from landowners and farmers to energy, waste and water companies to do more to protect this iconic and pivotal species.  

    Jon Shelley, Fisheries Technical Specialist at the Environment Agency said:

    We are proud that the Salmon Stocks in the Tyne remain “not at risk” and that rivers across the North East are providing a safe haven for salmon.

    However, we know the importance of this report and are not complacent in the North East. Action is needed to combat all pressures impacting salmon, to help maintain the salmon stocks in the region and improve the stocks across the country. 

    We will continue our vital work to help preserve the salmon stocks in our area by working closely with our partners and the community.

    Updates to this page

    Published 17 October 2024

    MIL OSI United Kingdom –

  • MIL-OSI USA: FEMA Support For North Carolina Surpasses $100 Million

    Source: US Federal Emergency Management Agency

    Headline: FEMA Support For North Carolina Surpasses $100 Million

    FEMA Support For North Carolina Surpasses $100 Million

    More than $100 million in FEMA individual assistance has been approved for North Carolina households affected by Tropical Storm Helene. 

    North Carolina Recovery By the Numbers

    All numbers and dollar amounts are as of close of business Oct. 15.

    • FEMA has made individual assistance available to 39 North Carolina counties and tribal members of the Eastern Band of Cherokee Indians.
    • FEMA’s Individuals and Households Program has approved over $102 million including:
      • $18.6 million to help homeowners and renters to pay for emergency home repairs, home replacement or other housing needs.
      • $83.6 million to help with other serious disaster-related needs, like moving expenses, childcare and disaster-related dental, medical or funeral expenses. 
    • Disaster Survivor Assistance specialists are in North Carolina communities helping individuals apply for assistance. As of today, these teams have registered more than 5,000 survivors. 
    • 6 Disaster Recovery Centers are operating in impacted areas, and to-date, have served more than 2,500 visitors. Even more centers will be opening in the coming days.
    • FEMA is providing temporary hotel stays to more than 2,000 households through Transitional Sheltering Assistance.  
    • FEMA inspectors have performed more than 14,400 home inspections.

    Disaster Unemployment Assistance is available in eligible, affected counties. For more information on this program visit des.nc.gov/dua or call 919-629-3857 (for Spanish call 919-276-5698).

    barbara.murien…

    MIL OSI USA News –

  • MIL-OSI Asia-Pac: Department of Animal Husbandry and Dairying progressively achieves targets set under Special Campaign 4.0

    Source: Government of India

    Department of Animal Husbandry and Dairying progressively achieves targets set under Special Campaign 4.0

    Focuses on Public Grievance resolution and cleanliness of office spaces

    Posted On: 17 OCT 2024 11:21AM by PIB Delhi

    The ongoing Special Campaign 4.0 is being implemented in the Department of Animal Husbandry and Dairying under the leadership of the Minister of Fisheries, Animal Husbandry and Dairying (FAHD) Shri Rajiv Ranjan Singh alias Lalan Singh, Shri. Prof. S P Baghel, Minister of State FAHD and under the overall guidance of Ms. Alka Upadhyaya, Secretary, Department of Animal Husbandry and Dairying(DAHD).

    Union Minister Shri Rajiv Ranjan Singh alias Lalan Singh launched the Special Campaign 4.0 at Krishi Bhawan, New Delhi on 2nd October 2024 in which Secretary, DAHD and all senior officers of the department participated enthusiastically. The field offices of the Department also launched the campaign with full fervor.

     

    With a view to implement the Special Campaign 4.0 in an effective and efficient manner, 9 sub nodal officers were designated in the Department. The Nodal officer of the department has chaired two meetings to finalize and review the progress of the targets for Special Campaign 4.0. The first meeting was held on 23rd September, 2024 to finalize the targets during  the “preparatory phase” of the campaign and the second meeting was held on 16th October, 2024 to review the mid-campaign achievement/performance vis-à-vis the set targets.

              

    Meeting held with sub nodal officers on 23.09. 2024          Meeting held with sub nodal officers on 16.10. 2024

    As per the data entered in Special Campaign 4.0 portal as on 16.10.2024, the status of achievement against the targets are as follows:

    Special Campaign 4.0

    Sl. No.

    Parameter

    Target

    Achievement

    1.

    Reference from MPs

     5

    5

    2.

    Parliamentary Assurance

    8

    0

    3.

    IMC References (Cabinet Proposals)

    0

    0

    4.

    State Govt. References

    0

    0

    5.

    Public grievances

    197

    110

    6.

    PMO Ref.

    2

    2

    7.

    Public grievances Appeal

    98

    7

    8.

    Easing of Rules/processes

    1

    1

    9.

    Review of Physical files

    10244

    10244

    10

    Review of e-files

    633

    513

    11

    Cleanliness of sites

    213

    156

     

    During the current campaign till date INR 8,42,753/- revenue has been generated which is significantly higher compared to the revenue of INR 4,52,213/- generated during the entire Special Campaign 3.0. The Department is committed to achieving the targets set for the Special Campaign 4.0 and will continue to put in the requisite efforts to ensure the timely achievement of the same.

    ****

    AA

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    MIL OSI Asia Pacific News –

  • MIL-OSI Asia-Pac: PRESIDENT OF INDIA VISITED MAURITANIA YESTERDAY

    Source: Government of India (2)

    PRESIDENT OF INDIA VISITED MAURITANIA YESTERDAY

    MET PRESIDENT OF PRESIDENT OF MAURITANIA; LED DELEGATION LEVEL-TALKS

    PRESIDENT MURMU ADDRESSED INDIAN COMMUNITY IN MAURITANIA

    INDIAN COMMUNITY’S SKILLS, EXPERTISE AND EXPERIENCE MATTER FOR INDIA’S PROGRESS: PRESIDENT MURMU

    FOUR MOUS IN THE AREAS OF TRAINING OF DIPLOMATS, CULTURAL EXCHANGE, VISA EXEMPTION AND FOREIGN OFFICE CONSULTATIONS WERE SIGNED AND EXCHANGED

    Posted On: 17 OCT 2024 11:12AM by PIB Delhi

    The President of India, Smt Droupadi Murmu, was in Mauritania yesterday (October 16, 2024), on the second leg of her State Visits to Algeria, Mauritania, and Malawi. On her arrival at Nouakchott-Oumtounsy Airport, President Droupadi Murmu was warmly received by the President of the Islamic Republic of Mauritania, H.E. Mr Mohamed Ould Ghazouani and accorded a ceremonial welcome. The Prime Minister and cabinet ministers of Mauritania were also present on the occasion.

    This is the first visit by an Indian President to Mauritania. The President was accompanied by the Minister of State, Shri Sukanata Majumdar, and Members of Parliament, Shri Mukeshkumar Dalal and Shri Atul Garg .

    The President addressed the members of the Indian Community in Mauritania at a Reception hosted by the Ambassador of India to Mauritania.

    Addressing the small but vibrant gathering of the Indian community, the President commended the Indian community for contributing significantly to the socio-economic development of Mauritania. She said that their skills, expertise and experience are also important for India’s progress.

    The President appreciated the Government and people of Mauritania for supporting the Indian community. She said that because of their inclusive and welcoming spirit, the Indian community in Mauritania is prospering.

    After the community reception event, the President visited the Presidential Palace where she held a meeting with President Mohamed Ould Ghazouani of Mauritania. Both leaders discussed ways to further strengthen the relationship between India and Mauritania. Subsequently, they led the delegation-level talk and witnessed the signing and exchange of four MoUs in the areas of training of diplomats, cultural exchange, visa exemption and Foreign Office consultations.

    Earlier, the Minister of Foreign Affairs, Cooperation and Mauritanians Abroad of Mauritania, H.E. Mr Mohamed Salem Ould Merzoug called on the President in a separate engagement.

    The President left for Malawi – the final leg of her three-nation visit.

    Please click here to see the President’s Speech – 

     

    ***

    MJPS/SR

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    MIL OSI Asia Pacific News –

  • MIL-OSI Economics: How AI is making eyesight-saving care more accessible in resource-constrained settings

    Source: Google

    Error 404 (Not Found)!!!</p> <p> <a href="https://blog.google/" rel="nofollow"><span id="logo" aria-label="Google"></span></a></p> <p><b>404.</b> <ins>That’s an error.</ins></p> <p>The requested URL <code>/around-the-globe/google-asia/how-ai-is-making-eyesight-saving-care-more-accessible-in-resource-constrained-settings/</code> was not found on this server.<br /><ins>That’s all we know.</ins></p> </p> <p>

    MIL OSI Economics –

  • MIL-OSI Russia: Artificial Intelligence Transforms Moscow’s Transport and Road Safety

    Source: Moscow Department of Transport

    The Moscow Department of Transport reported on the main projects related to Artificial Intelligence. From biometric payments to autonomous trams and advanced video analytics, AI-driven innovations are setting new standards in public transportation and traffic management.

    Artificial Intelligence Transforms Moscow’s Transport and Road Safety.
    • Biometric Payment Revolution

    For the past three years, biometric payment technology has been transforming the way people travel in Moscow. Available across all metro stations, Moscow Central Circle (MCC), Aeroexpress, regular river transport, and four Moscow Central Diameters (MCD) stations, this cutting-edge system allows passengers to pass through turnstiles with just a glance—no card or smartphone required.

    With bank-level security, this seamless service has already facilitated over 125 million biometric entries, making it one of the most convenient and secure transit payment systems globally.

    • Russia’s First Autonomous Tram

    Moscow is home to Russia’s first autonomous tram, a breakthrough in public transport innovation. This tram, equipped with a world-first set of technologies, operates without the need for external control systems. Its software, entirely developed by Metro’s in-house team, belongs to the Moscow Government and is unique across Europe.

    Since its introduction, the autonomous tram has covered over 1,800 kilometers without a single traffic violation, proving both its reliability and safety on the roads.

    • Sphere: The Video Analytics System Safeguarding Moscow

    The Sphere video analytics system has been instrumental in enhancing public safety across Moscow. Operational at all metro stations since September 1, 2020, Sphere helps law enforcement detain individuals on wanted lists and locate missing persons, including the elderly and children.

    Since its implementation, over 11,000 criminals have been apprehended, and more than 1,500 missing persons, including 300 children, have been located thanks to Sphere.

    • Real-Time Monitoring of Metro Carriage Load

    To further improve passenger comfort, Moscow’s metro now uses machine learning algorithms to monitor carriage load in real time. The system updates every 10 seconds, factoring in the type and capacity of carriages, major transfer points, and time-specific data. This unique service is available through the Moscow Metro app, offering unparalleled accuracy in carriage load assessments.

    • AI-Powered Moscow Transport Contact Center

    Since 2019, AI has been assisting passengers via Moscow’s transport contact center (dial 3210). A voice assistant automatically handles calls related to car evacuation, helping streamline operations. The contact center, operational for over 11 years, fields around 6,000 inquiries daily, providing crucial information on public transport, including fare rates, free parking availability, and more.

    • Advanced Video Analytics on MKAD and Major Highways

    Moscow has installed over 1,500 high-resolution cameras on the MKAD, MCD, and key roads, covering 100% of major routes without blind spots. These cameras detect 13 different types of incidents and send real-time video to the Traffic Management Center within seconds, allowing for rapid response. Thanks to this intelligent system, traffic accidents involving injuries on the MKAD have decreased by 20% over the last three years.

    • Leading the World in Photo and Video Traffic Monitoring

    With 3,800 cameras monitoring traffic across the city, Moscow’s photo and video recording system is one of the most advanced globally. The system, powered by AI, now detects drivers using phones or not wearing seatbelts, and as of 2023, it can accurately determine whether motorcyclists are wearing helmets and whether passengers are buckled up. AI also enables the detection of more complex violations, such as blocking intersections and failing to yield to pedestrians.

    • Smart Intersections Speed Up Traffic

    Moscow has introduced over 600 smart intersections equipped with AI-driven traffic lights. These lights adjust in real-time based on road conditions, using data from sensors embedded in the asphalt. As a result, both city and private transport pass through these intersections 25-30% faster, while pedestrians wait 20-25% less for the green signal.

    Moscow continues to lead the way in using AI to revolutionize transport and road safety, setting a global standard for innovation in urban mobility. With AI-enhanced systems in place, residents and visitors alike can expect safer, faster, and more convenient journeys across the city.

    MIL OSI Russia News –

  • MIL-OSI Canada: Statement by the Prime Minister on the International Day for the Eradication of Poverty

    Source: Government of Canada – Prime Minister

    The Prime Minister, Justin Trudeau, today issued the following statement on the International Day for the Eradication of Poverty:

    “Today, on the International Day for the Eradication of Poverty, we stand united to build a world where poverty is not just reduced, but eradicated. A world where every person has the chance to live in dignity, security, and comfort.

    “Reducing poverty and inequality across the country starts with building more affordable housing. Earlier this year, we launched our ambitious Housing Plan, which is helping build more affordable homes, faster, and addressing chronic homelessness, especially in underserved communities. Since 2019, the Reaching Home program has supported thousands of projects that have helped over 87,600 people across the country find a stable home and over 148,500 others receive homelessness prevention services, such as short-term rental assistance or help settling disputes with landlords.

    “The Canadian Dental Care Plan is helping millions of uninsured Canadians access affordable dental care – and 750,000 people have already received care. Our new National School Food Program will be getting healthy school meals to kids. This Friday, parents across the country will see the monthly Canada Child Benefit payment in their bank accounts. The program – which has lifted hundreds of thousands of kids out of poverty – puts money back in the pockets of Canadians. And with initiatives like $10-a-day child care and the upcoming Canada Disability Benefit, we’re making sure Canadians have the extra savings they need for the things that matter most.

    “Our commitment extends beyond our borders as well. Canada’s leadership includes our Poverty Reduction Strategy and Feminist International Assistance Policy, our commitment to advancing the 2030 Agenda for Sustainable Development, and most recently, the adoption of the Pact for the Future last month at the Summit of the Future. Just this year, we contributed nearly $1.3 billion to the International Monetary Fund’s Poverty Reduction and Growth Trust to lift countries out of poverty and make the world a better place.

    “Canada is steadfast in its commitment to building a future where poverty is eradicated and where every generation is given a fair chance to succeed.”

    MIL OSI Canada News –

  • MIL-OSI Russia: The Federation of Sports Programming of Russia has become a new partner of the State University of Management

    MILES AXLE Translation. Region: Russian Federation –

    Source: State University of Management – Official website of the State –

    On October 17, the State University of Management and the Russian Federation of Sports Programming signed a cooperation agreement.

    The document was signed by the Vice-Rector of the State University of Management Vitaly Lapshenkov and the Executive Director of the Federation of Sports Programming of Russia Andrey Arbuzov.

    The meeting took place at the largest industry event in Russian sports – the Russia – Sports Power forum, which serves as a platform for discussing ways to develop the sports industry in the country.

    The forum pays special attention to innovative sports that are becoming increasingly popular. One of them is sports programming, which combines technology, creativity and sports skills.

    The signed agreement opens new horizons for joint work and development of innovative sports at our university.

    Subscribe to the TG channel “Our GUU” Date of publication: 10/17/2024

    Please note: This information is raw content directly from the source of the information. It is exactly what the source states and does not reflect the position of MIL-OSI or its clients.

    Please note; This information is raw content directly from the information source. It is accurate to what the source is stating and does not reflect the position of MIL-OSI or its clients.

    The Federation of Sports Programming of Russia has become a new partner of the State University of Management

    MIL OSI Russia News –

  • MIL-OSI United Kingdom: Progress for investment in Grangemouth’s future

    Source: United Kingdom – Executive Government & Departments

    UK and Scottish Governments step up plans to support workers at Grangemouth refinery, with immediate investment in skills and training.

    • UK and Scottish Governments respond to Petroineos’ decision to close the refinery with investment in local community
    • Forth Valley College mobilised to support affected workers with bespoke skills support
    • Energy Secretary reiterates UK Government’s willingness to engage on how the National Wealth Fund could fund viable Project Willow outcomes, working with trade unions and industry

    The UK and Scottish Governments are jointly stepping up plans to support workers at the Grangemouth refinery affected by the risk of redundancy, with immediate investment in skills and training. 

    In addition to UK Government and Scottish Government’s joint £100m investment in the Falkirk and Grangemouth Growth Deal, Forth Valley College will receive funding to deliver bespoke support for workers affected by Petroineos’ decision to decommission the oil refinery.  

    Backed by this £100m funding, workers at Grangemouth refinery at risk of redundancy will be contacted in the coming weeks and offered tailored support to access new jobs in the local area that will shape the future of Grangemouth as an industrial hub for years to come.   

    Forth Valley College will shortly begin contacting workers to start building a skills and support package to meet their individual needs, mapping their current skills and qualifications to the future skills needed for local clean energy roles in the area and analysing where the gaps are. 

    The UK and Scottish Governments will use the findings to deliver targeted interventions to upskill the local workforce ahead of redundancies next year.  

    It comes as UK Energy Secretary Ed Miliband and Cabinet Secretary Gillian Martin attended a meeting of the Grangemouth Future Industry Board today (Thursday 17 October) at Forth Valley College alongside UK Energy Minister Michael Shanks, Scotland Secretary Ian Murray, local industry leaders, Falkirk Council, trade bodies and trade unions.  

    The £100 million Falkirk and Grangemouth Growth Deal will support projects and skills interventions in the local area. It is estimated that the Falkirk & Grangemouth Growth Deal will deliver over £628 million in economic benefits and create 1,660 jobs across the Falkirk Council area. 

    The Energy Secretary also reiterated the UK Government’s willingness to engage on how the National Wealth Fund could back projects that have the potential to yield a viable long-term future for the site, as part of the ongoing Project Willow investigation into a viable industrial Grangemouth.  

    Project Willow is urgently assessing credible options to begin building a new long-term industry at the refinery site, including low carbon hydrogen, clean eFuels and sustainable aviation fuels on the site. The Scottish Government will also soon publish the draft Grangemouth Industrial Just Transition Plan. 

    UK Government Energy Secretary Ed Miliband said:

    We continue to stand with Grangemouth workers and we are putting money on the table to secure workers good onward employment.

    By working in partnership with the Scottish Government, we’ve unlocked an unprecedented joint investment plan to support workers and secure Grangemouth’s future, and I will continue to spare no effort to drive this work forward.

    Scottish Government Cabinet Secretary for Net Zero and Energy Gillian Martin said:

    Our immediate priority remains to support the workers directly affected by the regrettable closure of the refinery. We will do everything we can to ensure they are supported to retrain and move into adjacent industries within the wider Grangemouth area.

    These workers are highly skilled and have an important contribution to make locally and nationally.  Our investment will help to unlock valuable new opportunities for them and ensure that their skills and experience continue to benefit industry in the area and the wider community.

    The new skills and training package is open to workers at both Grangemouth and Finnart Oil Terminal and will also be supported by the UK Government’s Office for Clean Energy Jobs.

    Kenny MacInnes, Principal of Forth Valley College, said:

    Forth Valley College are uniquely placed to help and upskill any Petroineos employees who are impacted as a result of the closure of the oil refinery, and we will be there to offer the necessary training and support with the help of funding from the Scottish and UK Governments.

    The College is proud to have had a long term partnership with the Grangemouth Refinery – helping to train their Modern Apprentices – and will continue to build on this in our role of making learning work for the people of Forth Valley to ensure they have the skills for the future.

    We are committed to working with PACE (Partnership Action for Continuing Employment) and Falkirk Council to help guide former Petroineos employees onto courses at Forth Valley College which will help them transfer to new jobs in another industry or sector.

    Notes to editors 

    See details of the joint investment plan.

    Updates to this page

    Published 17 October 2024

    MIL OSI United Kingdom –

  • MIL-OSI United Kingdom: Powerful new fostering film launched

    Source: City of Portsmouth

    ‘Everything’ launched on 17 October. It is the seventh film produced by a growing partnership of councils and children’s trusts to promote local authority fostering. The ‘Everything’ project is the largest collaboration yet.

    Cllr Suzy Horton, Cabinet Member for Children, Families and Education at Portsmouth City Council, said:

    “The ‘Everything’ project has given Foster Portsmouth an amazing film that shows the long-term impact fostering can have, with relationships between carers and children lasting well into adulthood.”

    “All councils need to recruit more foster carers, and by collaborating to produce this emotionally powerful film, we will show people how rewarding and life-changing fostering is.”

    “The message is the same for all of us; we need more people to step forward and become foster carers. ‘Everything’ will help us to reach more people in our communities and encourage them to find out more about this really rewarding role.”

    “We are committed to giving vulnerable children and young people we care for the best chance to thrive.”

    ‘Everything’ follows foster carer Mike and his family on a journey through time with two of the children they have looked after, who are now adults. Will and Zara take time to reflect on how being fostered made a difference to their lives, and thank Mike for ‘everything’.

    Thanks to footage shot on a genuine old camcorder, we are taken to the 1990s to see how Will settles into the family alongside Mike’s son Chris and the 2010s when a young Zara is being taught to play the guitar by Mike.

    The concluding message of the film is that what you do with your life could forever change someone else’s – encouraging people to foster in order to make that change.

    Project Director, Rachel Brown describes the main message of the film:

    “Many people don’t realise how common it is for relationships made through fostering to last well beyond the ‘official’ caring role. This has a huge impact on the lives of those who have been fostered, giving them stability and security well into adulthood.

    “We also wanted to reflect how the children of foster carers make a difference to children when they come into care, helping them to feel part of the family.”

    “Having over 100 councils taking part in the project, the film will reach a very wide audience, encouraging people to find out more and take the steps towards becoming a foster carer.”

    “Fostering with your local council means you can better support local children and young people who need a safe and nurturing home where they can grow and thrive.”

    Sarah Thomas, chief executive of the Fostering Network says:

    “The Fostering Network has been proud to support the collaborative film projects since ‘Giants’ in 2017. It’s great to see local authority fostering services pooling resources to produce another amazing film. ‘Everything’ will help to amplify their message about the chronic shortage of fostering households, encouraging more people to come forward and foster.”

    “One of the main characters in the film, Chris, shows how important other family members are when it comes to fostering. This is something we champion throughout October, which is Children of Foster Carer’s Month.”

    View the film ‘Everything’ at: http://www.fosterportsmouth.gov.uk/everything.

    For more information on fostering with Foster Portsmouth, fill in our contact form, visit: http://www.foster.portsmouth.gov.uk, call the Fostering SouthEast recruitment team on 0300 131 2797 or email info@lafosteringse.org.uk.

    MIL OSI United Kingdom –

  • MIL-OSI Europe: ASIA/INDONESIA – Resignation and succession of archbishop of Makassar

    Source: Agenzia Fides – MIL OSI

    Thursday, 17 October 2024

    Vatican City (Agenzia Fides) – The Holy Father has accepted the resignation from the pastoral care of the archdiocese of Makassar, Indonesia, presented by Archbishop Johannes Liku Ada’.He is succeeded by Bishop Fransiskus Nipa, until now coadjutor of the same archdiocese. (EG) (Agenzia Fides, 17/10/2024)
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    MIL OSI Europe News –

  • MIL-OSI Europe: AFRICA/SUDAN – “The war in Sudan receives little attention, but the suffering it causes is no less”

    Source: Agenzia Fides – MIL OSI

    Khartoum (Agenzia Fides) – “I was saddened to hear about the recent developments in the military offensive in El Fasher and Khartoum, which targeted civilian homes, hospitals and places of worship. The conflict, which has already lasted over 17 months, has created a humanitarian catastrophe that can no longer be ignored,” said Paul Swarbrick, Bishop of Lancaster, Lead Bishop for Africa for the Bishops’ Conference. Bishop Swarbrick wonders why a conflict as bloody as that in Sudan is virtually ignored by the international media. “It is obvious that the tragedy in Sudan receives less attention from world media than other conflicts around the world even though the violence and suffering is colossal”, said the Bishop of Lancaster. “This is perhaps because it is considered less likely to escalate beyond the region and less likely to affect the global security situation. It is perhaps even considered a global ‘back-water’. However, the suffering of so many millions should be considered a global tragedy”.According to the UN World Food Programme (WFP), the war, which has been ongoing since April 2023, has displaced more than 10 million people from their homes. Some 25 million Sudanese are malnourished, 14 million of them suffer from acute hunger and 1.5 million of them are at risk of starvation or starvation. In the face of this tragedy, Bishop Swarbrick recalls that “the Church has more than a purely humanitarian concern”. “Of course, we should pray and work strenuously for peace. The Church exists on the ground at the heart of this unending tragedy. It makes present a loving Saviour who refuses to abandon those who suffer most and brings a hope for healing that world powers alone cannot give. Christ’s suffering is never in vain. He never loses sight of those whose needs are greatest.” The Bishop therefore calls on the faithful to pray and to raise awareness of the drama in Sudan: “I ask everyone to pray for Sudan, for the warring parties to lay down their weapons and prioritise peace so that humanitarian aid can reach those in desperate need. By uniting in prayer and raising awareness of the war in Sudan within our communities and to our political authorities, we can all do our bit to help, to restore hope to those currently enduring unimaginable hardships”. (L.M.) (Agenzia Fides, 17/10/2024)
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  • MIL-OSI USA: Modernizing Congressional Data – Senate Legislation and Amendments on Congress.gov

    Source: US Global Legal Monitor

    The following is a guest post from Andrew Reiter, a legislative data specialist in the Congressional Research Service (CRS) of the Library of Congress. Andrew previously blogged about an update on the Congress.gov API and Modernizing Congressional Data – Treaty Documents on Congress.gov.

    Continuing our series on modernizing the legislative data exchange behind Congress.gov, we are going to look at the next phase of the project – modernizing the exchange of Senate measures and amendments data.

    The Legislation collection is comprised of bills and resolutions, along with associated actions (including Action Codes), titles, sponsors, cosponsors, and committee-related activity. Legislation text is a separate collection on Congress.gov.

    When we began the process of modernizing the legislative data exchange, we worked closely with colleagues in the Secretary of the Senate and the Senate Sergeant at Arms. The complexities of legislation moving through the chambers had to be considered. To assist with this, testing scenarios were developed to ensure that action codes, committee referrals, amendments associated with Senate measures, cosponsor data, and action text were rendered properly in Congress.gov. We devoted considerable efforts to ensuring that updates to legislation were displayed properly, as well. With these vital elements in mind, we decided to utilize unique identifiers in the modernized data. Unique identifiers in the data exchange support specific and precise updates as measures or amendments move through the legislative process.

    We completed several rounds of testing to confirm that more unique scenarios were accounted for within the new data exchange. A variety of cases were presented to colleagues in the Senate, and their feedback and knowledge were essential in refining the modernized data exchange.

    You can search current Congress collection items, metadata, and full-text documents from the search bar by entering your search terms in the search entry box and pressing Enter on your keyboard or clicking the magnifying glass icon. By typing into the search bar, you are given the option to search only in the legislation collection. Bills may be searched by number or keyword from the search bar, search form, or Advanced search, which includes an advanced form optimized for legislation, a query builder for customized searches, and a command line search using SOLR query syntax. See Search Tools for details on using operators and fields in your search query. Legislation fields can be used in the search bar and the advanced search command line.

    Senate legislation and amendment data is also available via the Congress.gov API, where users can view and download data in a machine-readable format. To learn more about Congress.gov collections in the Congress.gov API and how to get started using the Congress.gov API visit the Congress.gov API GitHub.

    The modernized data exchange has empowered us to be able to move to a new phase of enhancements in Congress.gov. We look forward to sharing those with users as work is completed. Until then, happy searching!

    Subscribe to In Custodia Legis – it’s free! – to receive interesting posts drawn from the Law Library of Congress’s vast collections and our staff’s expertise in U.S., foreign, and international law.

    MIL OSI USA News –

  • MIL-OSI Europe: ASIA/INDIA – Bishops on the death of businessman Ratan Tata: “A beacon of compassion” esteemed by the Catholics

    Source: Agenzia Fides – MIL OSI

    Bangalore (Agenzia Fides) – “Ratan Tata was an icon among entrepreneurs, a visionary leader and a philanthropist whose indelible contribution to society will be remembered for generations,” said the Indian Bishops’ Conference on the death of the well-known Indian businessman Ratan Tata, who died on October 9 at the age of 86. The former chairman of the “Tata Group”, which operates mainly in the automobile sector, was a “beacon of mercy and generosity”. “Through the Tata Trusts and his numerous philanthropic initiatives,” say the bishops, “he changed the lives of millions of people by supporting the cause of the marginalized and playing a fundamental role in the development of India. His unwavering commitment to social justice, education, healthcare and rural development was closely aligned with the core values of the Catholic Church, particularly its mandate to serve the poor and the vulnerable,” the statement said. The moral and spiritual legacy of Tata, who was born into a family of Parsi origin, is particularly recognized for his “ethical leadership, integrity and commitment to social causes” that “set a new standard for corporate social responsibility in India.” In addition to his remarkable contribution to the Indian economy, “he did not lose sight of the need to help the underprivileged,” the statement said. The Catholic Church in India recognizes him as an “extraordinary human being” and hopes that “his inspiring leadership and boundless generosity” will inspire many people and entrepreneurs in India, especially the youth, to “work for the betterment of society and serve others with selflessness and compassion.” Catholics will work together with all Indian citizens from all cultural and religious groups “for a fairer and more balanced society, realizing the values that Tata upheld and lived throughout his life,” the bishops assured. The Claretian missionary George Kannanthanam, who lives with lepers in Sumanahalli near Bangalore, commented: “Tata was a great role model by putting the Christian principles of truth, justice, equality, humility and mercy into practice.” “He spent most of his wealth on the welfare of the weaker sections of the population. He created great institutions for social welfare and development that changed India’s social landscape. He supported educational centers to encourage youth,” the priest recalls. “As an entrepreneur, he stood by the workers and gave them dignity and hope. He made life better for the disabled and the elderly,” the priest continues, describing Tata as “a different kind of businessman, compassionate, guided by the Gandhian motto: When you make a decision, think whether it will benefit the poorest person in the country.” For all this, he was loved by the 700,000 employees of his 19 companies in more than 100 countries, with a net worth of $400 billion. For example, in 2012, when the Tata Steel Company in Jamshedpur was downsized from 78,000 to 40,000 employees, the entrepreneur ensured that all laid-off workers continued to receive their wages until retirement age. “A decision that is unprecedented in history anywhere else in the world,” Father Kannanthanam notes, recalling that Tata’s total contribution to various charitable initiatives is roughly estimated at around $100 billion. If “God loves a cheerful giver, God loves Ratan Tata very much,” he concludes. (PA) (Agenzia Fides, 17/10/2024)
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  • MIL-OSI Video: Closing Plenary: Collaboration for the Intelligent Age

    Source: World Economic Forum (video statements)

    Join this closing plenary to explore how the Global Future Councils can contribute to building intelligent economies and societies as the Annual Meeting of the Global Future Councils draws to a close.

    https://www.youtube.com/watch?v=pMNYfHyAhfM

    MIL OSI Video –