Tips for getting the CE Mark
The medical device industry seems to be in love with Europe.
Due to complaints about the U.S. Food and Drug Administration’s perceived inconsistency, risk aversion and foot-dragging, many in the device industry have turned to the European Union’s CE Mark for their initial regulatory approval. A survey earlier this year by Northwestern University researchers found that two-thirds of small American med-tech firms are getting European market approval first, compared with only 4 percent who report going the domestic route first and getting FDA approval.
But is Europe really a medical devices paradise? Cleveland nonprofit business development group BioEnterprise hosted a half-day event aimed at examining the U.S. and European approaches to device regulation. Following are four tips gleaned from a panel discussion on the benefits and challenges of forging down the European regulatory path.
Europe’s “no walk in the park”: It’s a “misconception” that it’s a quicker process to obtain the EU’s CE Mark over the FDA’s 510(k) clearance, according to Ray Ursick, president of regulatory consulting group REU Associates. “If you think it’s an easier pathway, it isn’t necessarily,” he said. The speed and quality of a regulatory review is highly dependent on the individual reviewer, so Ursick recommends companies follow a “parallel path” of both U.S. and European regulatory approaches.
Reuse the data: For companies that do go the European route first, the FDA is willing to accept European clinical data as part of its regulatory reviews, said Neal Defibaugh, vice president for clinical and regulatory affairs with spinal disc developer AxioMed Spine. Just be sure the clinical protocols in the foreign country match up with those in the U.S. and that the foreign trial has a patient population that’s representative of the U.S. Device companies are unlikely to get U.S. clearance with foreign data only, but they can use data obtained at foreign clinical sites to support U.S. regulatory submissions, said Daniel Schultz of consulting group Greenleaf Health.
It’s all in the approach: It’s a mistake to approach any regulatory body and simply ask “What should we do?” in terms of developing a plan to get regulatory clearance, said Ursick. Instead, tell regulators exactly how you plan on designing clinical studies and exactly why you’ll do it that way. Bring in statisticians who can provide the rationale for why you’ll submit the numbers your clinical approach calls for, Schultz said.
Watch out for drift: At clinical sites, beware of a “drift” in patient inclusion or exclusion criteria by enrollment staff, Defibaugh warned. That’s sound advice for any site, but even more relevant for overseas trials that bring potential distance and language barriers. Not only is it important to have a good training program for investigators and staff at the trial’s outset, but you have to “continually educate” them as the trial progresses, Defibaugh said.
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