MDD 93/42/EEC

Medical Device Directive 93/42/EEC

The new regulation MDR replaced the Medical Device Directive (93/42/EEC) on 26 May 2021. As of this date, certificates under the MDD can no longer be issued. From 26 May 2024, the requirements of the new MDR must be complied with by all medical devices regardless of their risk class. In 2023, Regulation (EU) 2023/607 was issued, extending the validity of certificates issued in accordance with the MDD Directive, and extending the transitional period during which devices, compliant with the mentioned directive, can be placed on the market.