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

By Megan Gottlieb and Evangeline Loh

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).

MDR and IVDR survey results

The data (October 2023) reports 17,846 MDR applications and 5,599 MDR certificates (page 14), compared to the June 2023 data, 13,177 MDR applications and 3,899 MDR certificates. The graph on page 14 appears to report the increase in applications and certificates between June to October as 35% and 43% respectively.

For the IVDR, the data reports 1,498 IVDR applications and 702 IVDR certificates (page 37), compared to the June 2023 data, 1,155 IVDR applications and 500 IVDR certificates. Similarly, the graph on page 37 reports the increase in applications and certificates between June to October as 30% and 40% respectively.

Language Requirements Overview

The EC updated the Language Requirements Overvi­ew documents (22 March) with information for France. The two separate tables with the national language requirements for the MDR and IVDR now include additional information for English acceptance of certain information in France.

Concluding remarks

Manufacturers should commence their MDR and IVDR compliance journeys now. The MDR and IVDR applications and issued MDR and IVDR certificates have been increasing, though the reviews are still protracted. The notified bodies have reported capacity. Team-NB has published official calls to action for both the MDR and IVDR. ­­­

For legacy medical devices, if manufacturers want to capitalize on Regulation (EU) 2023/607, the application to the Notified Body is required by May 26. And the signed contract with the notified body is required by September 26. We will continue to report on the proposed regulation to delay the compliance of legacy IVDs.

Emergo by UL recommends manufacturers review the guidance provided by their notified bodies as well as the Team NB Best Practice Guidance on the MDR Technical Documentation File (TDF) and similar guidance for the IVDR TDF. If a manufacturer lacks experience or resources, Emergo bu UL can help.  We at Emergo will leverage our experience to review the drafted TDFs and assist with the notified body application.