EU Regulatory Roundup, April 2024: EU On Cusp Of Regulatory Shifts Amidst Political Change

As the EU heads towards a period of political change, the month of April saw the seeds sown for a debate on the future oversight of medtech. 

The first public debate, moderated by Medtech Insight, on the future governance of the EU medtech regulatory structure attracted a great deal of attention in April.

Five high-profile experts, representing notified bodies and industry, were all in agreement that changes to the management and oversight of medtech regulations are critical. At the same time, there was a note of caution that stability is also critical to ensure the ongoing implementation of the EU’s Medical Device and IVD Regulations goes as smoothly as possible.

The debate took place against the background of an ongoing European Commission-sponsored Study on Regulatory Governance and Innovation for which stakeholder input has already been sought. The study is being carried out by Ernst &Young.

While focusing on the topic of notified bodies, Bassil Akra, CEO of Akra Teams consultancy, asserted that notified bodies need to remain a key part of the European medical device regulatory system “regardless of how it evolves.”

EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions, with Petra Zoellner, director of regulatory affairs (IVDR and MDR) at MedTech Europe, underscoring the importance of having a single centralized structure to take on all types of different regulatory roles. She suggested that it should have overall accountability for safe and effective medical devices reaching patients.

More Changes Ahead After Key Documents Are Adopted

Following the final plenary session at the European Parliament before the five-yearly European Parliament elections, end April is a good moment to reflect on what the EU medtech regulatory scenario currently looks like before a new set of faces at the parliament and commission potentially alter the balance of views.

The new parliament will elect a new president of the European Commission and then examine and approve the commission’s College of Commissioners. It will also determine who is president of the EU Council of the heads of state and government.

European Parliament Votes On Documents Important To Medtech

There was big news from the parliament this month – the vote to adopt the proposed amending regulation giving IVD manufacturers more time to comply with the IVD Regulation and allowing the launch of as much of the Eudamed medical device database as is ready as of late 2025.

The vote also means that manufacturers will need to forewarn authorities and other interested parties about anticipated device supply interruptions.

This came during the same session as parliament adopted the European Health Data Space Regulation.

The parliament had already adopted the AI Act in plenary on 13 March.

All these documents now need final agreement from the Council of the EU. This final step to adoption is expected imminently for all three documents, well ahead of when the current Belgian presidency of the Council of the EU passes to Hungary on 1 July.

Also worthy of note is that parliament has decided to revise the Packaging and Packaging Waste Directive into a new EU Regulation. This is a horizontal regulation, and its revision will have implications for the medtech sector.

News About High-Risk Devices

Medtech manufacturers now have a fresh opportunity for free scientific advice for certain high-risk devices from EU expert panels, with the European Medicines Agency extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024.

Manufacturers of class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body have until 30 June 2024 to sign up. Applications from small and medium-sized enterprises (SMEs) will receive special attention.

Interestingly, in other news, it emerged that just four devices were subject to a scientific opinion from an expert panel in the second year of reviews, compared with six in the previous year. These scientific opinions relate to class III implantables and IIb active devices intended to administer and/or remove a medicinal product.

Guidances

During the month, medical device consultant Maria Donawa, president of Donawa Life Science, gave some useful insights into understanding the complex guidance on the content of the clinical investigation plan for clinical investigations of medical devices, MDCG 2024-3. This is an important topic as there are frequently omissions in CIPS, including specification of a risk threshold.

Otherwise, when it comes to guidances, April was a relatively quiet month, apart from the publication of:

• MDCG 2024-5 guidance on content of the investigator’s brochure for clinical investigations of medical devices. The sponsor of the clinical investigation is required to summarize the clinical and technical data of the device under investigation in this brochure.

• The first revision of MDCG 2022-9 Summary of safety and performance template. This contains a helpful revision changes section.

Notified Bodies

In other news, Denmark now has its first notified body under the MDR, TÜV SÜD Denmark, and France its second, AFNOR. This brings the total number of notified bodies designated under the regulation to 46.

Top Ten

The table belows show the most  popular 10 EU regulatory articles published in Medtech Insight in April 2024 among our subscribers:

UK and Switzerland

There was other interesting news in the UK and Switzerland (not part of the EU), including:

• UK MHRA Updates Assistive Tech And Borderline Regulations
• UK Medtech Strategy Sets Out Schedule Of Milestones to FY 2026
• UK Body Proposes Contract To Expedite Clinical Trials
• swissdamed Database Needs A Few More Months With UDI Model Now Underway