Brussels starts healthy debate on Medical Device Recast

  • Posted on 08.02.2011

Brussels starts healthy debate on Medical Device Recast


John Brennan

Director Regulations and Industrial Policy

debate brussels

Recent events in Brussels are pointing to a fresh, healthy airing of views and more robust debate on the Recast. (By the way, I’ve noticed that everybody says ‘Recast’ but not too many people know what a ‘Recast’ is. So for all those legal and regulatory ‘techies’ among you, click here, all others steer clear!).

To help foster a collaborative approach and input into the Recast, Eucomed has met several times with the Commission voicing our commitment to support and facilitate the type of forums where this can happen. This work is coming to fruition.

One recent example was the Commission workshop on the recast, convened on 18 January 2011.  Initiated through Eucomed discussions with DG SANCO late last year, the Commission accommodated a large cross-section of industrial stakeholders in a discussion workshop on some key elements of the Recast, namely pre and post market controls and governance of the system.  Pitched at senior level, this really was an excellent occasion to get clarity on the fundamentals. Quite quickly it was obvious that there is enormous overlap between industry and the Commission on ‘WHAT’ needs to be fixed. The ‘HOW’ was also discussed, but with a little less overlap, and here the Commission will be coming back to the debate for more feedback prior to the summer.

A second example is the High Level Conference on Medical Technology Innovation and Regulation on 22 March.  As a follow-up to the Commission’s Report on the Exploratory Process into this industry last year, this Commission initiative is a very welcome forum and is very much in line with the type of follow-up Eucomed was seeking. The March event is the first in what is hoped to be a series of high-level conferences seeking to put policy around the ideas captured in the report. The High Level Conference is aimed at Health Ministers and Senior officials and will invite back participants to the Exploratory Process.

Finally, and sandwiched between the two above, yours truly was invited to speak on behalf of European industry opposite Ms Jacqueline Minor at the Informa Lifesciences regulatory conference last week in Brussels. If you want a recap of my speech, please check out the press release.  Ms Minor is the Director of Consumer Affairs at DG SANCO and is the Director responsible for the Recast proposal, due in early 2012.  For those who missed it, or missed her speak at the Eucomed MedTech Forum last October, you really have missed an opportunity to hear both clear and straightforward explanations on Commission policy, and a genuine expression of openness to new ideas and a more full debate. Medical Device Authorities were also in the audience and Ms Minor made clear her desire to reach out to them in the very near future.

I would leave it to the audience to determine but personally I heard three important things from Ms Minor.  First, the Commission is thinking ‘evolution not revolution’.  Second, the Commission is seeking to keep time and costs the same, and is even looking at reduction if possible.  And third, use of EMA to help manage the system was still an open question and the Commission had not yet decided; she mentioned other solutions including the idea of the Commission, perhaps advised by the Commission’s Joint Research Centre, working together with the Member States – on the face of it this sounds decentralised and sensible to me.  Don’t know what the Joint Research Centre is? Then check it out here.

Then of course there is all the other recast-related events and stuff going on where Eucomed is working with the Commission and other stakeholders.  But I think I’ll save that information for our members discussions.  Speaking of which, I expect our Regulatory and Public Affairs Member Groups to be very, very, active in 2011 – seeing as the Recast is only going to affect how our industry runs its business for the next 10 to 20 years!  So, if you’re not already part of our Regulatory and Public Affairs Member Groups, it could be just the right time to join…

– John Brennan, Director Regulatory and Technical Affairs, Eucomed

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