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Simplification of Medical Device Regulations

Summary

The proposal aims to reduce the administrative burden on manufacturers of medical devices and in vitro diagnostics, particularly for small businesses. It seeks to improve efficiency while maintaining high safety standards through better transparency and oversight.
10 30.06.2026
Other
health
industry
administrative law
public administration
information technology and data processing

Key points

  • The proposal aims to significantly reduce the administrative and financial burdens on small and medium-sized enterprises (SMEs).
  • Certificate validity could be extended indefinitely following a successful re-assessment, providing more certainty for manufacturers.
  • Fee reductions are proposed for micro-enterprises and producers of orphan or breakthrough devices to ensure market access.
  • Safety and performance summaries must be written in plain language so that patients can easily understand them.
Documents (PDFs)
DRAFT OPINION on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
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