The adaptation of the transitional periods for the IVDR, published by the EU Commission in the form of Regulation (EU) 2024/1860, came into force on 9. July 2024 and is intended to give manufacturers...
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...
