Source: European Parliament
B10‑0126/2024
European Parliament resolution on the urgent need to revise the Medical Devices Regulation
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.