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Early Europe Approvals for Medical Devices Could Fade

Faster approval times have made Europe an early market for new medical devices, with U.S. approval often following a few years later.


That could be changing as regulators in the U.S., Europe and Japan look to unify their approval processes, according to an article on investor website Seeking Alpha.


“The geographical strategy that device makers have historically relied on may change now that we’re seeing greater regulatory convergence among the three major markets for device makers,” said Debbie Wang, an analyst with Morningstar Research Inc. who wrote the article.


The bad news for device makers is that approvals could become tougher in Europe, rather than easier in the U.S., according to Wang.


In Europe, medical device makers now are required to show the risk-to-benefit ratio of their products based on clinical data.


Before, they only had to show the safety of the device at the time of implant with no effectiveness requirements.


Post-marketing registries to track patients now are mandatory in Europe.


Wang said she expects device makers to face a longer clinical process, as well as higher development costs in Europe.


“This could lessen the incentive to head for Europe first,” she said.


Typically, device makers introduce products in Europe, followed by Food and Drug Administration approval and then a Japanese launch about three years after U.S. approval. Wang’s piece also addressed some changes underway at the FDA.


“Much uncertainty” surrounds tightening standards for the FDA’s 510 (k) medical device clearance program for approving devices similar to those already on the market, she wrote.


Earlier this year, the FDA released a report containing more than 70 proposed changes to the program.


Some 3,000 medical device applications per year, or a majority of those submitted to the FDA, are evaluated through 510 (k).


“Considering over 85% of medical device approvals are handled through (the process), versus the more rigorous premarket approval pathway, we can see why the medical device companies are sitting on pins and needles to see how the dust settles,” Wang said.