Has CE marking lost its appeal for developers of new medical devices?

Medical technology companies are increasingly turning to the FDA instead of the European CE mark when launching new products, according to a new report.

“Historically, CE marking has been the preferred route for registering new medical technologies because its processes were faster, cheaper and more predictable. The situation is now reversed,” write the authors of the study, published by Boston Consulting Group and the UCLA Biodesign Innovation Hub.

They surveyed and interviewed executives and executives from 102 companies that achieved registration or approval for 105 new technologies combined. Just over half of respondents said they deprioritize CE marking over FDA approval.

Of the companies surveyed, 90 are headquartered in the US and nine in the EU. A fifth of companies are listed on the stock exchange.

Industry leaders have described product registration and approval as “burdensome and uncertain” under the EU’s new Medical Devices Regulation (MDR) for patient and provider safety.

“Common complaints centered on the cost and time to re-register current SKUs, as well as expectations for clinical studies and language translation requirements,” the authors wrote. “Small businesses expressed these sentiments most forcefully, while some executives of multinational medical technology companies were more circumspect, speculating that the MDR could indeed raise the average quality of products in the EU market by reducing the number of undercapitalized new entrants.”

FDA guidelines for registration of traditional medical devices were described as highly or somewhat predictable by 62% of respondents, while only 22% said the same about CE marking. On the same question concerning digital, 32% of respondents consider the FDA route foreseeable compared to 15% for CE marking.

The report cited encouraging FDA launches such as changes to medical device user fees to eliminate backlogs, the innovation pathway and fast-track pathway to accommodate new trial designs, designation groundbreaking device to encourage innovation and the digital health center of excellence to offer guidance for digital offerings.

Brexit could also be partly responsible for this change. The UK will accept CE marking until June 2023 when it transitions to its own regulations. “Creating a separate review process for one of Europe’s largest markets diminishes the overall value of CE marking and will likely alter the risk-reward equation over the next decade as medical technology companies will roll out their new offerings,” the study said. “For EU residents, the likely impact will be delayed access to new and improved medical technology.”

The FDA’s gains may not last long, as survey respondents noted that contracting opportunities in the U.S. and overseas may eventually require the same parameters as MDR, “again giving products and EU-compliant companies a competitive advantage,” the researchers said. .

The report also compared the average review time in the EU and the US from first communication to clearance, and found that CE marking (before MDR) was faster than FDA clearance. 510(k).

Respondents cautioned that their conclusions are based on the opinions and biases of volunteer participants whose positive or negative experiences with regulators may have influenced their decision to participate, among other study limitations.

“Despite these limitations, this is the first study in over 10 years that attempts to provide an industry-wide perspective and benchmarks on industry experience with programs, processes and authorities. regulatory and reimbursement in the United States and in the global regulatory theater,” the researchers said.

The report can be read in full here.

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