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...
in December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN ISO 13485. The standard DIN EN ISO 13485:2021 contains requirements for a...
In the new position paper MDCG 2022-11, which has been published by the European Commission, manufacturers are requested to submit their applications for certification under MDR early and completely. ...
