ivdd

The medtech industry in Europe is made up almost uniquely of Small and Medium-sized Enterprises (SMEs). These have brought incredible innovations to patients, healthcare systems, the economy and society, and will continue to do so in the future. But if we put ever more data demands on these companies, in return, they need to be able to operate in a clear, efficient and predictable funding environment. Pop-quiz: What is the most innovative industry in Europe, measured by patents filed? It’s not the ICT industry. No, it’s not the pharma industry neither… It’s the medical technology industry, a sector that in general files over 10,000 patents per year. And it’s the SMEs that make up 95% of this sector in Europe that are the drivers of innovation. These deliver value at every level: Patients live longer, healthier lives Healthcare systems can use products that make more efficient use of limited resources European economies benefit from a brake on rising healthcare expenditure, while The medtech industry creates jobs (over 575,000 of them!) and growth (a positive trade balance of €15 billion). The medtech SMEs in Europe form a rich ecosystem that we cannot simply equate to the pharmaceutical sector, which in Europe is predominantly made up of multinationals and has product lifecycles of 10-15 years. At the same time, healthcare systems want more data and evidence of the value of innovations. The medtech industry, including SMEs, are committed to providing this data. However, while large multinational companies can easily move around (human) resources to cope with the additional work, this is much more difficult to do for companies that work with staff of between 1 and 250 people. Moreover, new legislation set to be introduced in a number of member states will considerably impact how innovations get reimbursed. Germany for instance has...
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.
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...
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 industry, fully agree with the need for adequate data on safety and accuracy of our products. But we need to make sure the requirements are tailored to the specificities of our industry. Clinical evidence what? Don’t worry if clinical evidence requirements do not immediately ring any diagnostic bells with you. They’re not often front page news on the FT. And when thinking about evidence requirements for medical technologies, one easily thinks of medical device requirements which assess whether the therapeutic effects of a device are indeed what they claim to be and what its impact is on the patient’s well-being. When it comes to IVDs, it’s a whole different game, first and foremost because in this case we’re not ‘treating patients’. What IVD manufacturers have to demonstrate are 3 things: scientific validity, analytical performance and clinical performance. Scientific validity basically is about answering the question: what is the meaning of the result you can read off of a test? Or in real terms: what is the meaning of high glucose in a diabetic patient (insulin may be needed to control it). While for established assays the scientific validity is well-known, for new diagnostic tests such as novel genetic tests or companion diagnostics, this is not the case, and the scientific validity of these assays will have to be determined before they can be made available for widespread use. Analytical performance needs to demonstrate whether an IVD can accurately measure what it is supposed to measure...
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.