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When I was first offered the position at Eucomed as a Communications trainee, I must admit I hardly knew what medical technology really was. After a little bit more than two weeks work, I realise that medtech is actually all around us. Take for example, the Olympics…

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.

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.

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?

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.

For medtech companies, interacting with Healthcare Professionals (HCPs) is a fact of life. HCPs are an integral part of the R&D process and a source of innovation and creativity throughout the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical devices in Europe, the US and beyond. With the adoption of new anti-bribery laws in a number of countries, increasing enforcement and new pressures from investors and the general public, the International Medical Device Industry Compliance Conference on 9-11 May in Stockholm, is well-timed to provide a platform for stakeholders to discuss these mounting challenges.

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.

Innovation is synonymous with progress. Embracing innovation means embracing the need to improve the sustainability and efficiency of healthcare systems by encouraging new business models, unlocking new market opportunities and improving health outcomes. Uptake of innovation in technology and services, however, could be quicker on the European healthcare scene, with myriad barriers currently standing in the way.

Centralised procurement of medical technologies is an increasingly prevalent phenomenon in the EU, and one that all stakeholders in this field, whether for or against it, have strong opinions on. Purchasers have embraced centralised procurement as a means to drive down costs. Suppliers fiercely oppose it as it would limit market opportunities and slow down adoption of innovations. Some experts believe that centralised procurement might actually have a negative effect on quality of care in the long run, as it focuses too much on short term cash savings.