Information on MDR implementation
The European Medical Device Regulation 2017/745 (MDR) came into effect on May 26, 2021, but a transition period applies to existing Class IIa products and Class I medical devices, which will be classified higher in the future, in accordance with Article 120 MDR. Dreve Dentamid GmbH may place these existing products on the market until May 26, 2024 under the Medical Device Directive 93/42 / EEC (MDD). The requirements of the MDR for post-market surveillance, market surveillance, vigilance and registration of economic players are of course fully met by Dreve Dentamid GmbH – also for existing products.
The following class I products will in future be classified under MDR as class IIa medical devices and will also fall under the transition period:
- FotoDent® tray
- Zerosil soft
We are already in close contact with our notified body regarding our MDR certification so that we can continue to offer you new innovative products.
Unna, June 2021