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We recently read the blog post “Improving access to medical technologies for diabetes care in Europe” from the International Diabetes Federation Europe assessing issues in terms of access to medical technologies for people with diabetes. As a producer of technologies and devices for people with diabetes, we keep learning and, when necessary, adapting our practices to fill in the gaps highlighted by IDF Europe.

As AdvaMed and Eucomed prepare for our next Global MedTech Compliance Conference May 20-22, 2014 in Barcelona, Spain, I reflect on the remarkable policy outcomes attributed to our past conference discussions.  Our MedTech association-led compliance conferences offer a platform—not available in a commercial compliance conference—to spur discussion and best practices exchange among compliance leaders on […]

In 2008 Eucomed published its revised Code of Ethical Business Practice. We’re six years on now and we’re thinking about writing a new one. Why? Because so much has changed in the world of medtech compliance.

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.

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire.  The sweeping changes being made to risk classification will be complex and time-consuming.  The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.

Judging by the weather in Belgium (currently 10° and raining) you wouldn’t say it, but it’s almost summer. Well, at least according to the calendar. And apart from the supposed good weather, summer also brings with it a host of new information on the MedTech Forum. Speakers are being confirmed, registrations coming in and preparations being made. Less than 5 months from now, we will all be seeing each other again at the event no one in our industry can afford to miss. So what does the MedTech Forum hold in store this year.

By now most of you will have noticed that we have launched our “Don’t Lose the 3”-campaign. (If you haven’t, watch the 1-minute video and patient stories here. The basic message of the campaign is that, thanks to our decentralised approval system for medical devices in Europe, Europeans have access to life-saving and life-enhancing technologies three to five years before US patients without compromising safety. This is also the message I brought forward during the 26 February hearing of the ENVI committee at the European Parliament.

If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.

First off, let’s start with some background. The first question that comes to mind would be: “What is the EUnetHTA Joint Action 2?” Briefly put, EUnetHTA, the European Network of Health Technology Assessment, is a joint initiative of the European Commission and the relevant agencies in the Member States, aiming to strengthen cross-border HTA collaboration.