ARTICLE SUMMARY:
Manufacturers’ efforts to satisfy clinical data requirements in Europe continue to be frustrated by a limited view into what notified bodies expect and an inconsistency in those expectations lining up with the understood risk and knowledge gaps for a device. A look at some of the systemic challenges and efforts to improve the status quo, including structured dialogue, standards, guidance, and experiments in evidentiary flexibility.
Device companies continue to run up against significant barriers to meeting clinical data requirements in the EU. Clinical expectations under the Medical Device and IVD Regulations, particularly for the vast number of low- to moderate-risk devices, too often don’t line up with the risk and clinical context of the products, experts say. On top of that, companies aren’t able to talk to notified bodies about the details of expected investigations in advance of carrying out clinical development plans.
“Clinical data ... are required for all devices in some form or fashion in Europe” outside of the limited and still-ambiguous exceptions, explains Maria Donawa, MD, president of consultancy and CRO Donawa Lifescience. But, she says, “It’s very difficult for companies to understand what is going to be required.”
According to Tom Melvin, MD, an associate professor of medical device regulatory affairs at Trinity College Dublin, the challenges of achieving transparent and consistent clinical data expectations in the EU are embedded in the origins of Europe’s regulation of devices. Melvin, who is a former regulator and current member of the European Medicines Agency (EMA) expert panels for the MDR, has been researching the historical basis of EU compared to US device regulation. FDA’s device framework, he explains, was developed in direct response to public health risks posed by unvetted medical devices, leveraging scientific principles to create its risk-based regulatory system. In Europe, on the other hand, economics and trade were more central drivers. “There was a big trade imperative to try and focus the single market in Europe, and that was really the start of our laws in Europe,” he says.
With the MDR and IVDR, he suggests, more rigid requirements for notified bodies and device companies have been introduced in Europe, but they haven’t been underpinned by the scientific and clinical study principles that allow FDA to modulate its expectations more flexibly for different technologies. “All of us now have to try and build proportionality into our work and into understanding what might be acceptable or not,” he says. “And this has all kinds of ramifications for clinical development strategies and getting similar approaches to similar technologies.”
Clinical Data Requirements: EU vs. USTo access a recording of the webinar moderated by David Filmore, editor of Market Pathways, with Maria Donawa (Donawa Lifesciences) and Tom Melvin (Trinity College Dublin):
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Donawa and Melvin both spoke during a September 25 webinar presented by MedTech Leading Voice and Market Pathways (see box to the right), part of an ever-growing public conversation about the persistent clinical data challenges for devices in the EU and ongoing work by government, notified body, and industry stakeholders to improve the status quo.
Indeed, much activity is afoot in the EU, including efforts to increase notified body-manufacturer interactions, develop new standards and guidance, roll out pilot programs and new flexibilities, and pursue more fundamental legislative reforms to the MDR and IVDR. But it remains to be seen how successful these efforts can be toward achieving more proportionality and clarity in clinical data requirements.
