MIL-OSI Europe: Written question – Support for small and medium-sized enterprises and challenges posed by the new Directive on liability for defective products – E-001194/2025

Source: European Parliament

Question for written answer  E-001194/2025
to the Commission
Rule 144
Nikolaos Anadiotis (NI)

The new Directive (EU) 2024/2853[1], which must be implemented by 9 December 2026, broadens the definition of ‘products’ to include software, digital files, raw materials, electricity and artificial intelligence. Companies can now be held liable for the malfunction and failure of these products, with, for example, compensation claims possible for personal injury, damage to property, loss of data or personal data breaches. Liability extends to manufacturers, importers, distributors and agents, i.e. everyone in the supply chain.

The directive includes provisions that shift both the obligation to comply and the burden of proof to producers, especially for complex products. The changes are expected to increase the cost of compliance for small and medium-sized enterprises (SMEs), particularly in countries such as Greece, where there are many such businesses and they continue to face economic challenges. It should be noted that in Greece there are 73 SMEs per 1 000 inhabitants i.e. 82 % more than the European average, which is 40[2].

In light of the above:

What specific measures does the Commission intend to take to help SMEs, particularly in Greece, to adapt to these regulatory changes without undermining their competitiveness and economic recovery?

Submitted: 20.3.2025

  • [1] https://eur-lex.europa.eu/eli/dir/2024/2853/oj/eng
  • [2] SME Country Fact Sheet Greece, European Commission Ref. Ares (2016)1073191, https://ec.europa.eu/docsroom/documents/15766/attachments/14/translations/en/renditions/pdf.
Last updated: 2 April 2025

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