Latest news

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.

The MDCG has published a guidance document in which it sets out the specifications for distributors, importers and notified bodies in accordance with Article 16(4) in more detail. This describes the prerequisites for a situation in which distributors or importers repackage medical devices or translate associated information without becoming manufacturers themselves.

EU: MDCG guidance on Article 48(6) IVDR

The MDCG has published guidance regarding the interpretation of the phrase "first certification for that type of device" in Article 48(6) IVDR. This article relates to a consultation procedure within the context of conformity assessment for Class D products, provided no CS are available and it is the "first certification for that type of device".

In mid-July, the EU published the first implementing decisions with harmonised standards regarding the regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the Official Journal.

EU: Guidance on the integration of UDI requirements into a quality management system

The EU has published new guidance (MDCG 2021-19), which deals with the processes required for the creation and maintenance of the UDI, as well as their integration into the manufacturer's quality management system.