ARTICLE SUMMARY:
European clinical groups say the MDR and IVDR lack a methodological framework to appropriately align clinical expectations with different device types. Establishing these principles under the leadership of the European Medicines Agency should be a top priority of oncoming reforms, according to a consortium of clinical societies. Tom Melvin, a professor, regulatory expert, and clinical advisor to the EU, spoke to Market Pathways about the proposal, which he helped coordinate.
The European Commission asked for input on how things are going with the Medical Device and IVD Regulations, and they got it. Five hundred eighty-four organizations responded to a December-to-March consultation with letters—some detailed and constructive, some more scathing in criticism—pointing out gaps and frustrations with the current framework, and recommendations for how to improve it. The consultation is meant to inform what the Commission is calling a “targeted evaluation” of the MDR and IVDR, suggesting a surgical effort to tweak certain specific elements of the regulations. But the breadth of some of the submissions makes the case for a more fundamental reform.
“As long as we keep providing guidance that could apply as equally to a heart valve as to a wheelchair, we're going to struggle to get the kind of detail that a developer needs at the start of their translational journey.”
One such entry came in a 52-page report compiled by the Biomedical Alliance in Europe, a consortium of 35 different European medical societies, from cardiology to orthopedics to urology and elsewhere across the spectrum of clinical care. The medical device industry has, of course, been active in advocating for change to the system, and we recently spotlighted companies’ key priorities and considerations in an in-depth interview with MedTech Europe. But clinicians are also looking to elevate their voice in influencing the direction of reforms, and the Alliance report frames their position.
It argues that the regulations are not underpinned by cohesive scientific and clinical principles that can serve as a basis for establishing clinical expectations for a diverse set of medical devices, and that the necessary governance is missing to implement such principles. The result in some cases, they suggest, is a lack of access to needed technologies that face unreasonable bureaucratic delays, and, in other cases, the necessary evidence is missing to support adoption of new technologies.
“We need a methodological framework,” says Tom Melvin, a professor of medical device regulatory science at the University of Galway and chair of the Biomed Alliance’s Regulatory Affairs Committee. “That would be one of the most important things for both medical devices and in vitro diagnostics, because as long as we keep providing guidance that could apply as equally to a heart valve as to a wheelchair, we're going to struggle to get the kind of detail that a developer needs at the start of their translational journey.”
The clinical group’s core recommendation is to expand the European Medicines Agency to include a medical device division, even potentially renaming it to the European Medicines and Medical Devices Agency. The proposal draws on the US FDA model while also recognizing the realities of Europe. It would retain the existing notified body infrastructure but seek to harness it to direct more bespoke clinical expertise and guidance for all categories of devices.
Melvin, who also participates in the EMA’s existing medical device expert panels and was previously a device regulator in Ireland and a medical doctor, spoke to Market Pathways about the plan. (The interview has been edited for clarity.)
