As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices...
On 20 Mar. 2023, the European Commission published Regulation (EU) 2023/607 extending the transitional periods for devices requiring a Notified Body for conformity assessment under Regulation (EU)...
As of Dec. 1, 2022, the European Commission published the definitions of common specifications for the devices without a medical purpose listed in Annex XVI of the MDR (Regulation (EU) 2022/2346. The...
By today's publication in the official European database NANDO, the list of Notified Bodies under Regulation (EU) 2017/746 (IVDR) has grown by another position with mdc medical device certification...
With the position papers MDCG 2022-4 and MDCG 2022-15, Notified Bodies are requested to identify relevant certificates (under Directive 93/42/EEC and 98/79/EC) which are subject to surveillance...
