The sudden arrival of proposals in late May to introduce fundamental and long-sought changes to the Medical Device Regulations took the entire sector by surprise.
The proposal for an amending regulation to the MDR came from an unexpected source – the European Parliament. The European Commission is the only one of the three EU institutions permitted to formally launch a new EU legislative proposal.
The latest text, prepared by MEP Peter Liese with the support of expert medtech lawyer and partner at Axon law firm in the Netherlands Erik Vollebregt, will remain just a proposal. But all eyes are now on the commission to see the extent to which it will pick elements of Liese’s document and formalize them.
But given that the new commissioners are still to be elected, including for Directorate General Sante which oversees medtech regulation, no further new document is likely to emerge until much later this year.
Picture Of Increasingly Broad Changes Comes Into View
The first element of news that emerged regarding the proposal was that the parliament wanted the five-year notified body review to be scrapped for most devices. The exceptions were class III devices and the majority of class IIb implantables, where it wishes for the recertification period to be extended from five to 10 years.
It then materialized that the proposals from parliament were far broader than this. Medtech Insight provided some of the highlights, including suggestions of how a new European medical device office could be created and the obstacles to innovation, and then a more lengthy step-by-step guide to the parliament’s text.
There is even speculation that the amendment to the MDR may be the first legislative proposal of the new commission, once elected, not least given the pressure that is coming from Germany.
The scene seems set for action later this year. This is especially the case as, in late June, the Council of the EU, the third EU party involved in agreeing new legislation, adopted a report on the future of the European Health Union that showed it supported change. In that report, the council invited the commission to “if appropriate, come up with a legislative proposal to address any identified shortcomings with a view to making the EU regulatory system sustainable in the medium- and long-term…”
In the background, however, is the question mark of how the newly elected commissioner and new MEPs will react to any future proposal. There are many competing urgent topics at EU level at the moment, and Oliver Bisazza, CEO of MedTech Europe, highlighted in an interview with Medtech Insight how important it is for the dust to settle and the new political leanings to be understood.
The urgency of the new measures was highlighted in a report from Deloitte, commissioned by MedTech Europe, which demonstrated how medtech businesses in Europe continue to lag in attracting investors while also facing mounting regulatory challenges.
One Amending Regulation Already Adopted
The long-awaited and already well advanced MDR/IVDR amending regulation was finally adopted at the end of May, enabling a gradual rollout of the Eudamed medical device database, further extending the deadline for transitioning to the IVDR for certain IVDs and requiring companies to forewarn about potential device supply interruptions.
But proponents of a much broader sweep of changes believe a far more radical overhaul of the EU’s regulations is needed, and urgently.
More On Innovation And AI
Bisazza, who addressed the issues of innovation at regular intervals during the Medtech Forum, told Medtech Insight that EU legislators need to regulate “with more of an eye to how Europe is benchmarked against the rest of the world.” The barriers that increasing EU regulation are creating to innovation, he said, are impacting all industrial goods.
Still on the subject of innovation, the MedTech Europe CEO also called on the EU to create an effective and efficient regulatory infrastructure for AI to prevent the AI revolution becoming a “huge missed opportunity” for medtech.
Notified Bodies
Turning back to the subject of the parliament’s proposal for an amending regulation, Vollebregt explained in a June interview why parliament has suggested centralized oversight of notified bodies through a European medical device office.
He considers there is a lack of harmonization of notified body administrative procedures and the MDR and IVDR would function better if these were more harmonized.
Regarding notified bodies, the good news in April and May was the number of designations that took place:
- QMD Services, Austria;
- Kiwa Belgelendirme Hizmetleri, Turkey;
- MTIC InterCert, Italy;
- AFNOR Certification, France; and
- TÜV SÜD Denmark.
In other notified body news, BSI became the first to publish lead times under the medtech regulations.
It also emerged in a survey by trade group TEAM-NB that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.
Guidances
Separately, May saw the publication of a flurry of guidances related to clinical investigations. The first was MDCG 2024-5: Guidance on content of the investigator brochure for clinical investigations of medical devices. It was published along with a series of preliminary assessment and reassessment review templates under the MDR and IVDR.
In June, guidance MDCG 2024-10 on the clinical evaluation of orphan medical devices was published.
Top Ten
The following is a list of the most popular articles with Medtech Insight’s subscribers: