European Clinical Investigations with Medical Devices are now governed by the Medical Device Regulation (MDR) 2017/745 + update 2023/607
- 6 nov 2025
- 1 minuten om te lezen
Replaced EUās MDD 93/42/EEC and EUās directive on active implantable medical devices (90/385/EEC)
Promotes a shift from the pre-approval stage to a life-cycle approach
Greater emphasis on clinical data and the Clinical Evaluation
Will include a specific group of devices (Annex XV; e.g. contact lenses)
New definitions and expansions to existing definitions
Monitoring for defective products
Metamorphosis of the NBs from industry partner into a police-like extension of the Competent Authorities marker surveillance apparatus
Safety reporting required pre- and post-market (e.g. periodic safety update report)
A quality Management System: to be initiated really soon in your product development
MedDev 2.7/1 Revision 4 and the Medical Devices Regulation will diverge in some areas: knowledge of both will be important during the transition.
Plan ahead to ensure compliance for MD currently under development and donāt forget that this legislation will also be applicable to your current and historic products.
EU regulation 2023/607 of 15 March 2023 has extended the MDR transitional period as displayed in the figure below:
