Clinical Data Requirements: EU vs. US – Key Differences and Strategies

Medical device manufacturers face starkly different regulatory landscapes when entering the U.S. and European markets.

Understanding these complexities is critical to ensuring compliance and market access as clinical data requirements continue to evolve. Ahead of our upcoming webinar, Clinical Data Requirements: EU vs. US – Critical Differences and Strategies, I sat down with the moderator David Filmore , and expert speakers Maria E. Donawa, M.D. , President of Donawa Lifesciences, and Dr. Tom Melvin , Associate Professor of Medical Device Regulatory Affairs at Trinity College Dublin.

During our pre-webinar discussion, they shared some off-the-record insights on how clinical data regulations differ between these two major markets and what manufacturers need to know to navigate both successfully.

#1: The Stricter European Approach

According to Dr. Donawa, European regulations impose rigorous clinical data requirements, even for lower-risk devices.

“In Europe, clinical data is required almost everywhere, including for many Class IIa and IIb devices,” she explained.

These heightened requirements often lead to increased costs and time delays, creating significant challenges for manufacturers trying to enter the market. Dr. Melvin added that this environment is particularly tough for startups and smaller companies.

“Manufacturers in Europe often struggle to get clear advice, which makes it difficult to develop a predictable regulatory strategy,” he noted.

#2: The Flexibility in the U.S.

In contrast, the U.S. offers more flexibility for certain device classes.

“For many Class II devices, clinical data may not be necessary, which allows for a faster and more cost-effective regulatory pathway,” said Dr. Donawa.

This flexibility can significantly reduce the time required for FDA clearance, making the U.S. a more attractive market for some manufacturers.

#3: The Challenge of Combining Clinical and Non-Clinical Data

Both experts agreed that while combining clinical and non-clinical data is sometimes possible, it does not always guarantee acceptance by regulatory bodies.

“Manufacturers can bolster their submissions with bench testing and non-clinical data, but it’s not a given that these will be accepted,” Dr. Donawa said.

This ambiguity adds an extra layer of complexity, particularly in Europe, where guidance can be unclear.

#4: The Need for Clear Guidelines in Europe

Dr. Donawa and Dr. Melvin emphasized the importance of clearer regulatory guidelines in Europe, especially around what constitutes “sufficient” clinical evidence.

“In Europe, the standard for ‘sufficient clinical evidence’ is not clearly defined, which leaves too much room for interpretation,” said Dr. Melvin.

Dr. Donawa echoed this sentiment, noting that a more structured approach would benefit manufacturers navigating these requirements.

Join the Webinar

Join us on September 25th for our live webinar featuring Dr. Donawa and Dr. Melvin to learn more about these critical differences and gain actionable strategies for compliance.

This webinar will provide real-world examples of how EU and U.S. clinical data requirements can impact market entry and offer practical tips for manufacturers. Register now to hear from two of the leading clinical data regulation experts.