February 2021

Key Updates on the European Medical Device Market – October to December 2020

Expert Lukas Block details some of the guidance documents published by the Medical Device Coordination Group (MDCG), including Guidance MDCG 2020-16 clarifying the classification for in vitro diagnostic medical devices.

October: A Bit of Everything

On October 6, the MDCG issued guidance regarding the vigilance systems of insulin infusion pumps and integrated meter systems to help manufacturers correctly identify reportable incidents.

In preparation for the go-live date of the first EUDAMED module, the European Commission updated its EUDAMED website on October 20 to provide additional information about the EUDAMED Actor registration module.

November: IVDR Is Coming

With the MDR application date getting closer and the IVDR on the horizon, the MDCG published guidance MDCG 2020-16 clarifying the classification for in vitro diagnostic medical devices. This guidance answers questions regarding definitions and every classification rule.

Additionally, TEAM-NB, the European association of notified bodies active in the medical device sector, published a position paper regarding the date of application of the IVDR. The association raised a red flag regarding the available and necessary guidance and capacity until the date of application.

December: Ups and Downs

The first EUDAMED module became available on December 1. Actors can now create an EU account and register as actors in EUDAMED. This applies to competent authorities, notified bodies, manufacturers, authorized representatives and importers. A successful registration will result in receiving the single registration number which will be required for several instances in the new legislative framework.

Regarding Brexit, rules were agreed for the future EU/UK relationship. Some products (e.g. medicines) received special treatment and extended collaboration. However, medical devices will be treated as “general goods” so the EU and UK must be viewed as separate markets from now on.

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