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.Learn more
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".
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.
EU: MDCG guidance on IVDR codes
The new MDCG 2021-14 contains explanatory information about the codes, which includes the scope of the designation for the notified body.