We were pleased to host Jennifer D. Newberger (Hyman Phelps & McNamara), Jenifer Hannon (BSI) and Sue Spencer (QServe) for a panel discussion at our recent Spotlight on medical devices event. Here we've summarised the key insights from this session on the evolving approach from the FDA, MHRA and EU Commission on medical devices regulation.
Changing requirements for clinical data
There has been a noticeable shift in the requirement for clinical data in both the US and EU. While the FDA's requirements remain unchanged on paper, an unwritten expectation of larger study sizes means that small companies now face prohibitive costs for studies. Similarly, the EU's Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have necessitated more extensive guidance from the Medical Device Coordination Group (MDCG) due to challenges in meeting regulatory requirements with smaller patient cohorts.
The in vitro diagnostics (IVD) sector faces its own set of challenges with increased regulatory demands and evolving technologies, creating a complex environment for compliance. This is new for many companies with over 90% of IVDs now requiring a notified body under the IVDR, compared to around 20% under the In Vitro Medical Device Directive (IVDD) previously. These updated requirements have also meant that notified bodies have had to enhance their in-house expertise to ensure thorough dossier reviews by knowledgeable experts.
How this is posing a challenge to the industry
The industry faces significant challenges for both medical devices and IVDs. In the IVD sector, many manufacturers are unprepared for impending regulatory changes and are lacking in experience with regulatory bodies, resulting in inadequate technical files. On the MDR side, there is a wide range of capabilities among companies. While high-risk device manufacturers are generally better prepared due to familiarity with stringent requirements, medium- to low-risk device manufacturers often struggle with obtaining clinical data and understanding post-market surveillance requirements.
Interacting with regulators and expert panels
Interacting with regulators and expert panels is crucial for navigating the complex regulatory landscape of medical devices. The FDA enables early conversations to set clinical study expectations, although timing of initial engagement with the FDA is critical as premature or delayed engagement can be counterproductive. Under the MDR, manufacturers can seek advice on clinical evidence strategies from expert panels, which is particularly beneficial for high-risk devices seeking scientific or clinical guidance but offers limited help to those struggling procedurally with conformity assessments. The Medical Device Coordination Group (MDCG) also offers general compliance guidance for companies but is unable to help with individual submissions.
Convergence and global harmonisation
The panellists observed increasing signs of global harmonisation in medical device regulations. They noted behind-the-scenes similarities between FDA and EU regulations, suggesting potential convergence driven by industry needs for streamlined studies across jurisdictions. The Medical Device Single Audit Program (MDSAP) scheme was highlighted as indicative of future harmonisation efforts, with regulatory bodies now communicating more frequently to promote a globally co-ordinated approach.
In conclusion, the insights from the panel addressed several key areas:
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The challenges arising from clinical data requirements.
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How the industry is responding to this challenge.
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Strategic approaches when engaging regulatory bodies and expert panels.
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Promoting global harmonisation through increased communication between regulatory authorities.
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