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In vitro diagnostic (IVD) tests are likely to be a part of everyone’s life, in many cases, more than once. Yet most people do not know what these tests are or what they do.

When we speak about healthcare in Europe, the word ‘sustainability’ is used often. From the outset of the economic crisis in 2008, policymakers, ministries of health, customers and payers all have focused on sustainable financial systems and sustainable healthcare systems – often as separate paths to achieve results. As budgets are shrinking, innovative ways to maintain current social and healthcare systems for the long term must be employed. At CleanMed Europe, a conference that brings environmental and healthcare issues together on the same agenda, I was pleased to see that a broader alternative discussion is emerging—one that marries financial and systemic sustainability in healthcare.

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.

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.

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.

This week a very interesting group of people met on the last day of the ESC Congress (European Society of Cardiology) in Munich. Representatives of the Eucomed CRM Telemonitoring Working Group, individual member companies and leading representatives of the ESC came together under the chairmanship of the European Heart Rhythm Association (EHRA) to officially launch the White Paper “Moving towards good practice in reimbursement of CIED Telemonitoring”.

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?

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.