[Emergo, UL] EU Recap: March 2024 was a Month of Many Medical Device Regulatory Updates

March in Europe

The European Commission (EC) updated several medical device safety regulation documents in March 2024. This includes additional standards harmonized with the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR) and published in the Official Journal of European Union (OJEU). It also includes an updated study on Notified Body applications and certificates and minor revisions to the EC language requirements overview documents.  

In addition, the EC published a new Medical Device Coordination Group (MDCG) guidance document on the content of the clinical investigation plan (MDCG 2024-3) and updated the ongoing MDCG guidance documents.

 

Additional standards harmonized to the MDR and IVDR

Two EC Implementing Decisions were published (March 6)  to release another set of standards considered as harmonized with the MDR and IVDR and posted in the OJEU. Standards are identified in each legislative decision.

The EC has also consolidated all the Harmonized Standards as summary lists for medical devices and IVDs.

 

Study on medical devices and IVDs and Notified Body Survey

The EC has updated (March 13) the data available from the survey on Notified Bodies and certifications and applications to the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR). The latest results represent the sixth survey and data through October 31, 2023.

The March report has an increased number of pages (to 54, from 39), which reflect data in Section 4 on notified body staff, as well as different statistics about the manufacturers. In addition, the EC’s dashboard for the Notified Body Survey results is featured (page 8).

 

 

EU Recap: March 2024 was a Month of Many Medical Device Regulatory Updates | Emergo by UL

EU Recap: March 2024 was a Month of Many Medical Device Regulatory Updates

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