Latest news

EU: Joint implementation/preparedness plan published

The EU has published a "joint implementation/preparedness plan" for the MDR, which presents the current status and priorities of the further activities regarding the implementation of Regulation (EU) 2017/745.

EU: Tenth notified body for the MDR

The tenth notified body for the MDR has been announced and entered in the Nando database – Norwegian organisation DNV GL Presafe AS.

EU: Documents on European Medical Device Nomenclature (EMDN) published

The EU has published two documents on the new European nomenclature for medical devices that is to be introduced: A brief opinion regarding EMDN and a document on the principle of the underlying Italian CND nomenclature.

The MDCG has published new guidance on cybersecurity with respect to medical devices in the form of MDCG 2019-16.

On 27th December 2019, the EU published the second corrigendum relating to the MDR and IVDR in the Official Journal of the EU.

EU: Additional bodies announced for the MDR and IVDR

MEDCERT, a body for the MDR, and BSI Group The Netherlands B.V., a body for the IVDR, are the two newest notified bodies. With these new additions, there are now nine notified bodies available for the MDR and three for the IVDR.

EU: Guidance for Class I manufacturers published

The MDCG has published MDCG 2019-15, a guidance document for manufacturers of Class I products; it provides a step-by-step guide to the required tasks for placing a Class I medical device on the European market.