Europe

The only step that remains now before the  European Health Data Space Regulation is approved is sign off by the Council of the EU, due next month. Industry wants to see the new framework carefully aligned with existing EU legilsation.

The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.

Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

The EU now has a total of 45 notified bodies under the MDR.

The ownership of all study data would be granted to the non-commercial sponsor, says one of the many provisions proposed in the model investigator-initiated study agreement that the Health Research Authority has released for consultation.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

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.

Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.

The EMA is extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024.