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When the European Parliament finalised their amendments for the Proposal for a Regulation on in vitro diagnostic medical devices in October 2013, they set the scene for a process that has continued through several Council Presidencies. The continued discussions are a reflection of the complexity of the file and the need for careful consideration of the technical aspects of the text, which should lead to the creation of a positive environment for innovation, safety and patient access across Europe.

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 […]

I just read the minutes of the joint meeting EDMA, Eucomed, COCIR and EUnetHTA had last May and it got me thinking: why try to put a square peg in a round hole? Medical devices, in vitro diagnostics, imaging equipment and pharmaceuticals – while all health technologies – are very different in nature, in their mode of action, in the benefits they bring to people’s health and well-being, and in the way they contribute to sustainable healthcare. Because of these and many more differences, trying to apply a Health Technology Assessment (HTA) model designed for pharmaceuticals to other health technologies is like trying to shove a square peg into a round hole – it won’t work.

Safe and accurate In Vitro Diagnostics (IVDs) are essential to a safe, efficient and effective healthcare system. Policymakers recognise this and that’s why they have included a clinical evidence requirement in the upcoming revision of the IVD Directive (IVDD). Because IVDs play such a pivotal role in the treatment pathway of patients, we, the IVD […]

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.

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I’m sure the evolutions will provide me with plenty to blog about.