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Compliance In Focus
Posted by John Lehmann on Thu, Feb 28, 2013

Medical Device Makers and E.U. at an Impasse

As a follow up to our blog on Monday, February 25th, an article in MassDevice indicates thatMedical Device Makers and E U  at an Impasse medical device and European Union regulators are at a stalemate over new regulations proposed. The medical device industry supports reforming the current decentralized system by allowing a new Medical Device Coordination Group to request additional assessments. This comes in the wake of the breast implant recall that many believed revealed shortcomings in the E.U.’s regulatory environment.

This impasse comes right before the European parliament is set to host a public debate on a new regulatory system.  The medical device industry vehemently opposes these new regulations, which are similar in many regards to the system that is in place in the United States.  The medical device manufacturers fear that the new regulations will stall innovation, which has been a key selling point for the E.U.

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.

Eucomed has been front and center in this debate, advocating for the industry.  They agree that the system needs change, but oppose any radical changes that will they believe will delay devices 3-5 years.  Others argue that the system has not changed in decades and needs a radical overhaul to ensure patient safety and avoid the wide-scale breast implant recall that exposed weaknesses in the current system.

However, it was just last year that a new committee was established by the European Medicines Agency (EMA), called Scientific Coordination Board. According to a press-release, the group aims to ensure “sufficient coordination between the committees, so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment.”

The EMA also stated plans for the board to look into factors that may be “putting the system under pressure.” The issues included:

  • Increasing difficulties in sourcing appropriate experts due to the continuous strengthening of the rules on allowable conflicts of interests of the Agency’s experts
  • The continuous increase in the number and level of activities for all committees
  • Challenges from new scientific developments, for instance advanced therapies or personalized medicines, which require an integrated scientific and regulatory approach, from the drug development phase, starting with scientific advice, right through to post-authorization follow-up

It seems more revamping is on the horizon for the E.U. system. Although there seems to be general agreement that a change is required, is adopting a centralized system that mirrors the U.S. the best approach?

We will keep you posted on any new developments, but wanted to open the discussion floor to you. What are your thoughts on approval system in Europe compared to the U.S.?  Please feel free to share your thoughts and updates with us below.  

Photo Credit: StarrGazr

Regulations Revelations

Topics: Medical Device Makers, European Union, Regulations

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