US Companies Prefer FDA Approval Over CE Mark for Medical Devices
(Thursday, March 31, 2022)
Recent changes to medical device rules in the EU have made it harder to get CE mark and effectively pushed companies to seek FDA approval prior to the CE mark, found a recent survey of predominantly US-based companies. FDA is perceived to be more responsive and predictable compared to its European counterparts. Traditionally, US-based medical device companies used to launch products in the EU due to the lower entry barriers. The CE mark required fewer, if any, clinical testing, and simpler quality requirements, making it quicker and less expensive to commercialize new medical devices, particularly Class II devices. FDA had often criticized the laxity of the medical device rules in the EU which it believed led to devices with questionable benefits being available to patients in the EU. However, the Medical Device Regulation (MDR) in the EU changed all that. The MDR rules, that became effective in May 2017, require rigorous clinical testing for all Class II and III medical devices, higher quality standards, and strict post-market oversight. All previously CE marked devices had to be recertified. These new rules took away the perceived advantage of the regulatory process in the EU for the medical device companies, particularly those from outside the EU who primarily took their devices to Europe to test and commercialize new products prior to approaching the FDA for the same. Besides, the MDR rules are still being implemented and negotiations are ongoing for any exemptions for lower risk devices creating uncertainty. In this regulatory environment, the FDA’s 510k process seems much more predictable and attainable resulting in the shift of strategies to first pursuing FDA approval and then CE Mark. The survey found a few other aspects where FDA out-performs European regulators. FDA has taken the lead in digital health, artificial intelligence and machine learning-based devices with clearer guidance, FDA e-submission meetings have helped developers troubleshoot with the regulators effectively, the Breakthrough Device designation has allowed fast-tracking innovative technologies, and FDA’s statutory timelines for review of applications offer far greater predictability than similar processes for the CE Mark. The survey had some limitations; 9 out of 10 companies surveyed were US-based, 80% of these companies were private funded smaller companies with limited experience in EU, more than 90% of the respondents were working on Class II, 510k devices, where the differences are much greater than that for the PMA devices, and most respondents were individuals at the company and not a diverse groups who may have biased opinion based on personal experience rather than a company-wide history with either regulators. That said, the findings of the survey are still credible as they are based on logical and scientifically justifiable rationale. The 510k process is indeed much more predictable than the CE Mark under the MDR rules. And for Class II 510k devices, this FDA advantage over European regulations is likely here to stay.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC