In Vitro Diagnostics

“What a mess! … The MDR is a complete disaster,” critics tell European Commission.

With so many discussions around future change now in the medtech regulatory melting pot as 2025 kicks off, it is unsurprising to see an intense calendar of EU meetings ahead. But which topics deserve the most focus?

Medtech Insight spoke to eight well-known EU regulatory experts to find out what developments they expect to see, what they fear and their wish list for 2025.

Only a week ago, the European Commission launched a consultation to which medtech stakeholders were invited to reply. Now it has launched a survey. Why two separate calls in one month and how will that information be used?

New documents on clinical investigation reports, how to apply to notified bodies and the process of submitting information about devices being discontinued feature among nine critical new documents published by medtech authorities in December 2024.

Following the Council of the EU’s early December meeting, a strong consensus is emerging among industry and policymakers on the nature of many aspects of the much-needed reform of the EU’s medtech regulations.

With debate intensifying in the EU over potential EMA oversight of device regulation, life sciences lawyer, Alison Dennis, is advocating for a distinct European Devices Agency to streamline and improve current regulations.

There is considerable pressure now on the European Commission to complete its targeted evaluation of the EU’s medical device regulations and start rectifying many of its shortfalls that are impacting patients and industry alike

Centralized regulation will be beneficial for classification and borderline decisions, orphan device decisions, and recertifying notified bodies. But it is not a panacea for EU medtech in the view of Sabina Hoekstra-van den Bosch.

We do not want the commission to wait for its targeted evaluation before making regulatory changes to the MDR and IVDR, medtech industry representatives tell Galway meeting. They shared their vision of what could happen next.