The MedTech Europe blog

With the summer holidays well and truly behind us, and temperatures outside gradually dropping, I am sure the temperature inside the EU institutions is rising as the EU machine is picking up steam again. Commission portfolios have been handed out, the Commissioners-designate will soon be vetted, and certain competences are being moved from one Directorate-General to another. Make sure to read on to find out our thoughts on the move. And if that’s not enough ingredients to guarantee an interesting and exciting Q3 and Q4, we have our MedTech Forum that promises to be the biggest, boldest one yet.

It’s been a big month for the EU in this year of change—last week Commission President Jean-Claude Juncker officially announced the new College of Commissioners-designate and their respective portfolios. Of particular interest to our industry was the move of the unit for health technology and cosmetics which includes IVDs and medical devices from the Directorate-General for Health and Consumers (DG SANCO) to the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG ENTR) under the Polish Commissioner-designate Elżbieta Bieńkowska. This means that DG ENTR will take over the responsibility for the ongoing revision of the medical devices and in vitro diagnostics Regulations.

It seems this move does not sit well with many of our partners in health. I have read articles in both national and European press in which various stakeholders have voiced their concern. As MedTech Europe, EDMA and Eucomed want to be very clear on this issue.

Our #1 priority is to provide patients with access to safe, effective and innovative diagnostic and treatment options.

Our #1 priority is to provide patients with access to safe, effective and innovative diagnostic and treatment options. Of course, being an SME-driven industry in Europe, these very SMEs are just as critical and require an environment in which they can flourish. Thriving SMEs benefit patients and European economies alike.

We have an effective working relationship with DG SANCO, and see no pressing motivation for the portfolio to move to DG ENTR but nonetheless look forward to meeting Commissioner-designate Bieńkowska. We’re also keen to work with Commissioner-designate Andriukaitis and his team on HTA and eHealth issues. We hope that the change will not lead to delays in bringing the new MDD & IVD regulations to a balanced and implementable conclusion.

Another warm welcome is in order for Ms. Glenis Willmott, the UK MEP who has been appointed the rapporteur for the MDD file replacing German MEP Dagmar Roth-Behrendt. She’s well known as an expert on a range of health issues and has served as rapporteur for the recently revised Clinical Trials Regulation.

Meanwhile, I want to thank Ms Roth-Behrendt for her unique ability and conviction in moving forward the complex file that is the MDD Revision. At the same time, for IVDs, MEP Peter Liese is expected to continue his work on the file and represent the European Parliament. It has been clear from the beginning that with his experience in health Mr Liese has been committed to moving the dossier forward from the outset. And while official announcements on the rapporteur and shadow rapporteurs still have to be made, the ECR Group have indicated that MEP Boleslaw Piecha will be the shadow rapporteur for both files.

We certainly share both Ms Glenis Willmott and Mr Liese’s passion for driving legislation that puts patients and transparency first.

We certainly share both Ms Glenis Willmott and Mr Liese’s passion for driving legislation that puts patients and transparency first and look forward to engaging with both to ensure a regulatory frameworks for medical devices and for in vitro diagnostics that are able to efficiently address patient and user safety requirements, patient access to safe and effective medical technologies, effective and non-bureaucratic support systems to authorities and continued medtech innovation.

Where we also continue to innovate, is in our annual MedTech Forum. This year, we’re introducing interactive voting during the plenary sessions and, for the first time ever, we will have workshops by and about patients.

This year, I can also truly say that MedTech Europe has put together a “cream of the crop” selection of speakers and topics, with DG SANCO, PwC, McKinsey, E&Y, BCG, the Center for Disease Control & Prevention and many more set to present.

What has been working well in the past few years is being kept for this year’s edition. So rest assured that you will have plenty of opportunity to informally meet and discuss with your peers, join the social conversation on Twitter and actively participate in the workshops. If you haven’t done so, make sure to save your seat (those at the gala dinner are running out fast!) at and help answer the question: “More Needs, Higher Expectactions, Smaller Budgets – Can the MedTech Industry Deliver?”


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

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