This week, the European Commission unveiled a targeted proposal to amend the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) with the goal of cutting regulatory burdens on manufacturers while preserving high standards for patient safety and product performance.
Major highlights:
- Reduce administrative complexity and costs that have emerged since the MDR and IVDR were implemented, particularly those affecting small and medium-sized enterprises and the certification process.
- Proportionate and flexible compliance with risk-based approaches, including more adaptable requirements for regulatory roles and conformity assessments.
- A shift toward digitalisation and innovation-friendly pathways, including regulatory sandboxes and broader use of clinical and real-world evidence.
- Extended certification practices and updated post-market obligations that reduce repeated reporting while maintaining oversight.
- The proposal also supports smoother regulatory processes for legacy devices, breakthrough technologies, and orphan devices, and aims to align device rules with other EU legal frameworks where appropriate.
These changes are part of a broader EU initiative to improve the competitiveness, predictability, and resilience of the medical and diagnostic sector while ensuring continued high protection for health and safety.
More information could be read from the official European Commission press release:
New measures to make EU health sector more innovative, competitive and resilient