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Compliance In Focus
Posted by John Lehmann on Mon, Feb 25, 2013

Tougher EU Device Regulations

According to an article from Reuters, there is a clash brewing between medical device companiesTougher EU Device Regulations and the European Union.  This comes on the heels of the highly publicized breast implant (PIP) scandal that shook Europe’s confidence in its light-touch system for regulating medical devices.

The issue will be discussed in a February 26th meeting in a European Parliament committee meeting.  Although there seems to be general agreement that a change is required, National Governments are taking differing positions.  France is arguing that EU laws must be radically changed, while Britain opposed big changes.

As imagined this meeting has created much stir. A previous MassDevice story, pointed out that “The FDA requires that medical devices demonstrate safety as well as efficacy before winning approval to sell in the U.S. The EU system generally only requires safety studies.” Some believe that going overseas is the best way to gain approval because the process can be faster, and the products end up on the market much quicker then in the US. On the other had, An Oxford University teacher, Carl Heneghan, who has studied device recalls, pointed out the flip side is the European are almost like the test pool for these quick approvals. After all, it wasn’t too long ago that the PIP incident swept the globe. This in fact was an incidence of devices that did not gain U.S. approval but were widely available across Europe.

  • The essence of the debate is if the EU should adopt a centralized system that mirrors the United States
    • Eucomed does not support this thinking.  Eucomed represent medical device companies in Europe. Serge Bernasconi, CEO for the organization fears the shift will harm Europe’s leading position in devices innovation. He indicates, “If Europe were to switch to a centralized system, we expect that, once the new system is up and running, patients will experience an 3-5 unnecessary delay in receiving medical devices compared to today’s situation.”
  • The current EU system is built around 80 Notified Bodies, mainly private firm that are strewn around Europe

The medical device industry supports reforming the current decentralized system by allowing a new Medical Device Coordination Group to request additional assessments. They cite longer clinical trials for some so Class III or high-risk devices.

I think everyone agrees that something will be done, but what are your thoughts on revamping the EU system?  Please share them below.

Photo Credit: sacks08

 top 5 trial complications

Topics: EU Device Regulations, Eucomed, PIP Incident


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