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When Philippe Croizon broke his first world record by swimming across all four intercontinental channels in August 2012 he declared “I’ve got no big challenges in the near future but “never say never””. Here we are, only a few months later with yet another great achievement…

And what an achievement! As a big sports fan I have been trying to follow exemplary sportsmen, especially those whose lives have intersected with medical technology.

Health First Europe has always believed that by bringing together all health stakeholders, solutions for challenges in healthcare can be found that benefit all patients.  In 2012, we continued in our conviction that together we could better protect patients and improve access to treatment by working with the EU institutions and other EU health stakeholders. This past year, our work on patient safety and health technology assessment (HTA) produced concrete recommendations for policymakers on how the EU can support the improvement and delivery of care for patients.
In 2013, we will not only further our work on patient safety and quality of care, but also expand our issue engagement to look beyond safety and access, to patient empowerment, health literacy and community care.  Encouraging patients to be informed about their care is of great importance as health systems adapt and change to the meet the needs of an ageing population as well as shortages of healthcare professionals and tighter budgets for delivering care.

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.

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.

You’ve heard me proclaim the importance of MedTech SMEs before on this platform and I reckon you’ll hear me again. You’ve heard me tell you that SMEs are the backbone of this industry – that as 80 plus percent of a 95 billion euro industry they are what makes the sector tick, launching innovative technology on a rolling basis and driving European healthcare forward onto a sustainable path. Well it appears I’m not the only one keen to sing the praises of our brilliant community of big thinkers. MedTech SMEs are gaining new ground in Europe as more people realise the promise they represent.

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?

The current voluntary cooperation of Health Technology Assessment (HTA) agencies organised within EUnetHTA indicates that HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology.

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.