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EU – implementing regulation for EUDAMED database published

The EU Commission has published an implementing regulation relating to the EUDAMED database. This governs general questions, e.g. relating to access and registration.

The MDCG has published two additional guidelines in the form of MDCG 2021-25 and MDCG 2021-26, which address the implementation of the MDR for "legacy devices", specifically questions relating to outer packaging/labelling in accordance with Article 16 of the MDR.

The EU Commission has published a proposal for the step-by-step implementation of the in-vitro diagnostics directive, which enables manufacturers to place products in line with the previous directive on the market for longer. Find the press release here.

EU: Additional EUDAMED modules approved

After the module for registration of actors, the EU now also offers the modules for UDI/product registration and notified bodies/certificates, initially for voluntary use. Actors must log in to access these modules; other users can use them without logging in.

EU: New/updated MDCG guidelines published

The MDCG has updated guideline 2019-6 to version 3, which includes questions and answers relating to requirements for notified bodies. MDCG 2021-24 has also been added, containing information about the classification of medical devices.

EU: Expert committee for IVD begins work

Since the start of September, the expert committee for the IVDR has been accepting requests from notified bodies for consultation procedures relating to performance evaluation. An overview of the expert committees for the Medical Device Regulation and in-vitro diagnostics directive can be found here.

EU: Additional corrigenda in different language versions of the MDR

In July 2021, the EU updated several language versions of Regulation (EU) 2017/745 (MDR) in the form of additional corrigenda, including the German version. The most recent update corrects more than 50 translation errors. A consolidated version of the MDR with notes on the changes can be found here.