The Medical Device Regulation (MDR, (EU) 2017/745) was adopted in 2017 and replaced the Medical Device Directive (MDD). It has been in force since 26 May 2021. Medical device approvals will be gradually transferred to the MDR, with existing approvals expiring no later than the expiry of the current CE marking.
The development process for most medical devices is already complex, and the new regulatory requirements further increase the effort. Approval by Notified Bodies is currently a bottleneck in the process. Experts therefore assume that the transition to the MDR will be very time-consuming.
The MDR differs from the MDD in several respects, in some cases significantly:
- Extended scope
- Designation of a responsible person
- Introduction of a unique product number for traceability (Unique Device Identification, UDI)
- Strict post-market surveillance
- Introduction of common specifications applicable to both manufacturers and notified bodies.
- Reclassification of devices based on risk, contact duration and invasiveness.
- Strengthened clinical evidence requirement for class III medical devices and implants.
- Systematic clinical evaluation of class IIa and IIb devices
- No longer grandfathered - products already approved must be re-tested and re-certified.
These changes show that the MDR has more extensive requirements than the MDD. Manufacturers must adapt to these changes and adjust their products accordingly. We will be happy to support you with the transition!
