mdd

EU Parliament
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...
Clinical Evidence for medical devices
We’re right in the middle of a year of change in the EU. Europe has begun voting and EU politics may look quite different as a result. New things and new faces may be on the horizon but that doesn’t mean that work has stopped on a file of great importance to the Union’s more than 400 million citizens: the revision of the EU medical devices and in vitro diagnostics directives. Indeed, the EU Council, made up of health ministries from the EU’s 28 member states are hard at work tackling that task. On the diagnostics side, you can read my most recent dispatch on Clinical Evidence “for In Vitro Diagnostics” here . Eucomed, for its part, reiterated its points a few weeks back in an updated position paper . Today, I’d like to elaborate some more on the topic of clinical requirements, this time from the medical devices perspective. This issue is of such a critical nature we simply must get it right to make sure the final text of the Medical Device Regulations works for patients and innovation. Before I go into the topic I wanted to briefly touch on the timing aspects of the regulatory process. I sometimes pick up messages that the process in the Council is moving too slow and that this would be in the interest of industry. Let me be crystal clear that this is not the case. We are not looking to slow or speed up the process. What industry wants is the best possible regulatory framework that works for patients, regulators and industry. And the faster we have a good regulatory framework the better. And I am saying again: good, fair and balanced regulatory framework It’s now up to the trialogue partners to decide how long the process will take. Catering...
Where are we again on the MDD and IVDD?
The European Commission released its proposal for the revision of the EU Medical Devices (MDD) and In Vitro Diagnostics Directives (IVDD) in September 2012. The European Parliament weighed in on the file, voting on its final report in a plenary session last October. And in December we heard reps from the 28 EU health ministries voice their views on key issues. The word on the street is that the EU Council is set to reach its final position by June with trialogue discussions (where the Commision, Parliament and Council negotiate a final text) pencilled in for Q4 2014.
In Europe, health data are considered so sensitive that processing them is generally prohibited in the EU, unless that processing follows specific guidelines. For example, the prohibition does not apply when sharing data is essential to providing healthcare, where those data are handled by a Healthcare Professional (HCP) subject under national law and subject to professional secrecy laws. With the rapid growth in diversity of medical technologies though, more and more medtech companies are processing health data on behalf of HCPs.
Health will be one of the main topics at this year’s World Economic Forum. It is encouraging to see that the world leaders are recognising that health is a prerequisite for well-being and economic growth. And as a large contributor to health, our industry can play an important role in ensuring that people live longer active lives and contribute to this economic growth. One look at the rough outline of the different sessions and there are at least seven sessions that are of particular interest.
The year is nearing its end and as I look at the christmas tree being put up, the smell of pinewood slowly filling our office’s reception area, I cannot help but think that 2013 was a crucial year for patients, healthcare systems and Europe as a whole. This past year was dominated by one topic of mastodont proportions, but other actions, activities and achievements have been just as important to us.