Medical Device Directive (MDD)
The former EU regulatory framework (93/42/EEC) for medical devices, replaced by EU MDR 2017/745. MDD certificates issued by Notified Bodies remain valid until their expiry but can no longer be renewed under MDD.
The Medical Devices Directive (MDD 93/42/EEC) was the EU regulatory framework governing medical devices from 1993 until its replacement by the EU Medical Device Regulation (MDR 2017/745). While MDD has been superseded, it remains relevant because many devices still hold MDD certificates during the transition period.
MDD to MDR transition
MDD certificates that were valid before May 26, 2021 remain valid until their stated expiry date, but no new MDD certificates can be issued. Manufacturers must transition their devices to MDR compliance before their MDD certificates expire. The transition has been challenging due to limited Notified Body capacity, leading the EU to extend transition deadlines.
Impact on procurement
Procurement teams must distinguish between MDD and MDR certificates when evaluating tender submissions. Devices with valid MDD certificates can still be legally sold, but hospitals may prefer MDR-certified devices for long-term supply contracts. Tenders increasingly specify that only MDR Declarations of Conformity will be accepted, particularly for new framework agreements.