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...
The Basic UDI-DI is an important key in product documentation (e.g. certificates, technical documentation, vigilance notifications and PSUR, SS(C)P, etc.) and also serves as an access key to the...
At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the...
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)...
