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Compliance In Focus
Posted by John Lehmann on Wed, May 30, 2012

Four Tips on Navigating the Regulatory Environment in Europe

A MedCity News article provided four tips on how best to navigate the regulatory environment inNavigation Europe.  There is an increasing trend by medical device manufacturers to seek the European Union’s CE Mark for their initial regulatory approval.

Many blame the FDA’s inconsistency, risk aversion and long time lines for this growing trend.  The article cites a survey earlier this year by Northwestern University researchers who found that two-thirds of small American med-tech firms are getting European market approvals first, while only 4% seeking FDA approval.  These are pretty dramatic numbers.

Cleveland, Ohio-based BioEnterprise recently held an event that examined the U.S. and European approaches to medical devices and provided the following four tips:

  1. Europe’s “No Walk in the Park”:  Ray Ursick, president of the regulatory consulting group REU Associates indicates that it’s a misconception that the European regulatory pathway is faster.
  2. Reuse the Data:  The FDA is willing to accept European clinical data as part of its regulatory reviews according to Neil Defibaugh, vice president of clinical and regulatory affairs for AxioMed.
  3. It’s All in the Approach:  According to Ursick, it’s a mistake to approach any regulatory body and ask, “what should we do?”
  4. Watch Out For Drift:  Defibaugh warned that you need to be aware of drift in patient inclusion and exclusion criteria by enrollment staff. 

Many believe the trend to seek European regulatory approval will continue.  Do any of you have additional tips that can build on the ones supplied in the MedCity article?

Share your thoughts.

Photo Credit:  Matti

Topics: Regulatory Environment in Europe, BioEnterprise, AxioMed, REU Associates


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