My first twelve months at EDMA and Eucomed

  • Posted on 20.08.2013

My first twelve months at EDMA and Eucomed


Serge Bernasconi

Chief Executive Officer, MedTech Europe

12 months

While enjoying my holidays I was reminiscing a bit about my time in Brussels and thought I‘d share my reflections with you. A little over a year ago, on 16 July 2012 to be precise, I joined EDMA and Eucomed. As such, this “fait divers” is not that important, but since then a lot has changed that will impact our industries and associations.

To strengthen the medtech industry representation in Brussels, Eucomed and EDMA formed the MedTech Europe alliance which was launched at the MedTech Forum in September 2012. The Alliance is allowing both associations to work closely together on topics of strategic importance such as the 5-year industry strategy, various key new regulations, and joint representation on international level. I’ve really come to see that when Eucomed and EDMA work together on common policy objectives, such as the Transatlantic Trade and Investment Partnership (TTIP), we can be much more effective and efficient not only for our external stakeholders (e.g. they now only need to meet one organisation) but also for us internally (decision-making on joint topics is much easier to do when you have a structure in place).

Another project that took up a lot of our time in the past year and will continue to do so going forward is the revision of both regulatory frameworks. As these are very different in nature, they are both handled separately by EDMA staff and Eucomed staff. A few months into my new role, and about a month before the 2012 MedTech Forum, the Commission came out with its proposal for both revisions. And while we were generally happy with what was being proposed, there was one item in the medical device proposal that we strongly opposed, as you may remember: the so-called “scrutiny procedure”. In terms of the IVD proposal, our main concern is to ensure that the industry is given 5 years to implement the necessary changes. You can read all about it in this blogpost.

After the Commission proposals, a few months went by until in April the Rapporteurs for in vitro diagnostics, Dr. Liese, and medical devices, Mrs Roth-Behrendt, released their text in response to the Commission proposal.

Dr. Liese’s proposal was well-balanced and again our only concern is that we ensure that enough time is foreseen to carry out the proposed changes.

In terms of Ms Roth-Behrendt’s proposal, while we fully agree to a strengthened regulatory framework, the way it is proposed is not the right way forward. Establishing a centralised pre-market approval system as seen in the US, risks European citizens having to wait unnecessarily 3-5 years before being treated with a life-saving medical device. You can get the full lowdown and our scientific backing of this statement on

What I’ve taken away from my experiences of dealing with the European Parliament, the European Commission, the Council and other important parties is that it is truly possible to openly discuss each other’s positions. It’s critical that we first explain how our industry works because without that knowledge it is very difficult to understand why we propose certain recommendations. I think we still have a lot of explaining to do, in terms of how our industry operates, and I look forward to continuing the open discussions we’ve had with the various stakeholders in and outside Brussels.

And lastly, in line with the founding of MedTech Europe, we had to find office space which better accommodated the closer collaboration between EDMA and Eucomed. An air of openness, collaboration and creativity emanates from the premises we decided upon, and they reflect perfectly the trademarks that spring to mind when thinking about MedTech Europe. Moreover, the offices are located within walking distance of our main stakeholders and I’ve noticed that my colleagues are having more meetings with key stakeholders because it’s just easier to arrange and takes less time than before. I think the mere fact of moving to the European centre is improving our outreach and we now feel truly part of the European game.

Talk to you in September!

– Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA & Eucomed

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