EU Regulatory Roundup, December 2023: Sector Poised For A Rethink

As 2023 ended, the big question increasingly on everyone’s minds was the future direction of EU medtech regulation given the hurdles that are still being encountered with the implementation of the Medical Device and IVD Regulations, and the impact of the new measures on innovation for manufacturers in the EU.

This issue is expected to dominate 2024 as Europe’s largest industry association in this sector, MedTech Europe, calls for sector-wide discussions, including on proposals for a new single governance structure to be set up with oversight and responsibility for the sector.

Director of industrial policies IVDR-MDR at the Brussels-based association, Petra Zoellner, spoke in some detail with Medtech Insight about the shape that discussions could take. She explained that MedTech Europe envisages this structure overseeing notified bodies and having the right amount of mandate and empowerment to course-correct when problems are identified within the system as well as having a specific role in promoting and supporting innovation.

But it is not just a new governance structure that is needed in MedTech Europe’s view. Zoellner told Medtech Insight that the association’s goal now is, together with all impacted stakeholders, to co-create a vision for success in terms of a sustainable robust framework guaranteeing the structural deficiencies of the regulations are addressed with the right measure of efficiency, and enabling opportunities for innovation.

Eudamed And Class D IVDs

Among concerns voiced by the association in recent position papers are the timing of the launch of the future Eudamed medical device database to support the implementation of the MDR and IVDR and the readiness of manufacturers of high-risk IVDs to comply with the 26 May 2024 deadline under the IVDR.

These topics were addressed in subsequent papers on Eudamed and on class D IVDs that were released by the trade association in the second half of December. They were also raised by member states at the 30 November Council of EU meeting and were high of the agenda of the mid-December meeting of the European Commission’s Medical Device Coordination Group (MDCG) meeting.

MedTech Europe’s position paper on IVDs called for clearer policies for class D devices to give manufacturers a good chance of overcoming regulatory challenges in time.

During December there had been positive news concerning the future assessment of class D IVDs when the first batch of EU reference laboratories, critical in the assessment of high-risk IVDs going forward, were named in Commission Implementing Regulation (EU) 2023/2713.

They will not be required to start their activities until 1 October 2024.

When it comes to Eudamed, there is now talk of the database being launched as a set of five modules, before the clinical investigation module, the sixth, has been completed. If this becomes possible, it will mean that the database will provide the necessary support to underpin the medtech regulations sooner rather than later. 

And, when it comes to class D IVDs, MedTech Europe issued a 22-page position paper, entitled The clock is ticking – MedTech Europe’s recommendations ahead of May 2025 deadline for class D IVDs.

German-Speaking Associations Create Own Lobby Group

Against this EU level background push for change, Germany’s BVMed, Austria’s Austromed and Swiss Medtech have signed a special collaboration agreement where the goals include to create and preserve an innovation-friendly legal framework for the medtech industry.

The three associations plan to use their collective weight and combined lobbying voice towards further selected goals including: maintaining high-quality care for patients; positioning medical device companies as attractive employers for skilled workers; and supporting member companies with strategies to promote sustainability.

AI Act Progress Signals Hurdles Ahead

A provisional agreement for the EU’s Artificial Intelligence Act was agreed on 8 December after 36 hours of negotiation between the Council of the EU and the European Parliament.

The Act is now expected to enter into force in early 2024, with a transition period of two years, as long as final formalities go to plan.

All medical devices will be classified as high-risk AI and need to be certified under the AI Act as well as the MDR and IVDR. Uncertainty remains over the regulatory overlap for medical devices. To address this challenge, the proposed text attempts to integrate the AI Act with existing legislation (i.e. including the MDR and IVDR) but there could be hurdles ahead, with potential challenges for manufacturers and notified bodies alike.

European Health Data Space Nearing Reality

Additionally, the scene is now set for the European Parliament and the Council of the EU to negotiate the final text of the European Health Data Space, but there are points of contention which need to be resolved first and the outcome of future talks will dictate the extent to which the medtech industry will benefit from the initiative.

The EHDS is a platform designed to give EU citizens and healthcare professionals access to personal health data. This could be a valuable resource to the medtech industry and guide researchers to unmet public health needs, creating avenues for advancing therapeutics.

New And Revised Guidance Documents

In further news, the commission published two new guidance documents relating to Annex XVI products. (These are products with no intended medical purpose that generally offer aesthetic or well-being benefits e.g. dermal fillers and contact lenses that are regulated in the context of the MDR because they are used on or in the body in a comparable way to medical devices.)

The first new guidance document MDCG 2023-5, is a 14-page guide for manufacturers and notified bodies on the qualification and classification of Annex XVI products. The second, MDCG 2023-6, is a four-page guide for manufacturers and notified bodies on demonstrating equivalence for Annex XVI products.

Other guidance documents and updates published during the last month of the year were:

• MDCG 2023-7: Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on “sufficient levels of access” to data needed to justify claims of equivalence.

• MDCG 2019-7 Rev.1: Guidance on article 15 of the MDR and IVDR on the person responsible for regulatory compliance (PRRC).

• MDCG 2021-6 Rev.1: Questions and answers regarding clinical investigation under the MDR.

• MDCG 2021-27 Rev.1: Questions and answers on Articles 13 and 14 of the MDR and IVDR (relating to the requirements for importers and distributors).