The Medical Device Regulation (MDR) is slowly but surely replacing the previously applicable Medical Device Directive (MDD).
Provided manufacturers meet various criteria (for example, having submitted a transition plan by May 26, 2024), the deadline is extended, depending on the risk class. By September 2024, a contractual agreement on implementation with a notified body must also have been concluded.
For medical devices with an MDD certificate or a declaration of conformity issued before May 26, 2021, the transition period is extended as follows:
- May 26, 2026: custom-made implantable medical devices (class III)
- December 31, 2027: higher-risk medical devices (non-exempt class IIb implants and class III medical devices)
- December 31, 2028: lower-risk medical devices (class IIa, Ir, Im, Is) and products that only require a notified body for conformity assessment under the MDR.
The extension of the deadline was agreed in March of last year to give manufacturers more time to transfer their existing products to the MDR. The reason: because of a shortage of notified bodies, (rapid) certification under the MDR by the end of the deadline could not be guaranteed for all medical devices.