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 and IIb devices and class I medical devices that will be classified higher in the future in accordance with Article 120 MDR. Dreve Otoplastik 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 Otoplastik GmbH for existing products.
Otoform® impression material, hardener paste, Fotofix opaque and Otoferm cream are upgraded according to the classification rules of the MDR and thus fall under the transitional period in addition to medical devices of Class IIa and IIb.
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