Regulation
96 blogs about the topic
Industry involvement in EUnetHTA Joint Action 2 – Our experience is here for the taking
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.
Posted on 15.10.2012
Eucomed: proposed overhaul of EU reg system mostly positive with one caveat
The European Commission’s proposal to revise the medical device legal framework is a welcome step towards strengthening and improving the EU regulatory system. Recognised globally as being the fastest in providing life-saving technologies to patients without compromising safety, this thorough overhaul of the regulatory system seems to be mostly in line with Europe and President Barroso’s stated policy of ‘Smart Regulation’: ensuring the quality and relevance of EU legislation, which should benefit people and businesses.
Posted on 18.09.2012
Wedding bells are ringing for the proposal of new IVD regulation
I have always found that no matter how much a person looks forward to a change, there is still that little tad of reluctance – a fear that things may not turn out for the better. The hesitation, even if momentary, manifests itself in the simple and mundane everyday tasks like clicking install for a computer software update or taking life’s big leaps, like getting married. The concern for what the change may bring is all the greater when you didn’t really mind the way things were in the first place. From my experience, some of us in the in vitro diagnostics (IVD) industry are also experiencing a bit of such reluctance when it comes to the revision of the IVD directive. Especially when it has worked fine since 1998, so why the change? A reasonable question, but considering the differences that have arisen between the healthcare context of the late 1990s and today, it’s time that our industry give the proposal careful consideration in the lead up to its approval, taking into account the impact of each of the legislation’s proposed aspects.
Policy and regulation for innovation in mHealth
For the past two years, I have been working with great passion on the subject of mobile health (or mHealth), having set up the global mHealth programme of the GSMA – the organisation that represents the interests of mobile operators worldwide. I am therefore very pleased that the momentum for mHealth has really been building.
Posted on 25.07.2012
The impact of WEEE2 on the medical devices industry
The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:
Posted on 09.07.2012
How the approval process of medical devices works in Europe
Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system.
Posted on 02.07.2012
Toward the best possible solution in EU medical device labelling
In summer of 2011, the EU’s Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.
Why PMA is a step backwards in the approval approach for medical technology
Lately I hear and read a lot of people asking for a Pre-Market Authorisation process for medical technology in Europe, or PMA process as it’s known, similar to the one in the US. Even the European Parliament voted (narrowly) for a resolution in which they call for a PMA approach. And that made me think, hold on a second, don’t we already have an approval system in Europe for high risk products?
Posted on 09.05.2012
So where are we again on the Revision of the MDD?
There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what’s exactly going on and where we are exactly in the process.