Regulation

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.

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.

Having read Commissioner Dalli’s analysis of the PIP case and the Commission’s plans for strengthening the medical devices directives, it becomes clear that the medical technology industry and the Commissioner share the same view on safety and innovation.

Since the French authorities made their announcement just prior to Christmas, the PIP case has generated a large amount of press and political attention. Quite rightly, the main focus is on the women affected and on governments providing the right health advice and appropriate follow-up. As I am writing this posting a couple of days after we released our first statement, I understand that the European Commission is to seek an independent scientific opinion on the human health risks of silicone breast implants.

As the Euro zone crisis threatens to precipitate a much more fundamental questioning of the European dream, it is easy to revert to the eurosceptic homeland of vilifying apparently meaningless rules and regulations that have little real impact on the lives of any of us. The likes of the British ‘save our pint’ campaign trivialises the debate and does little to educate the voters of member states as to the real issues at stake.

My wife and I are part of the problem. Last weekend we ran respectable 10 kilometre times although we are both in the latter half of our fifties and we will play energetic tennis twice in the week ahead. Both had life expectancies in the early seventies at birth and now our risk adjusted life expectancies are straddle ninety years. We are a triumph for modern lifestyles and medicine (both having had interventions for conditions which may well have been fatal one hundred years ago) yet healthcare is the political scourge of our times. The success of society in increasing healthy productive years is matched by the failure of that same society to plan for such success in the provision of pension, health and social care. Yes, we have a financial crisis which has followed the profligacy of a generation but this is a minor issue compared to the need to rebuild our economic models to accommodate the demographic changes which us ‘baby boomers’ are so central to.

Not too long ago, I was invited to a friend’s 40th birthday party. As many other guests I came up with my best wishes and cheers stressing the benefits of getting “settled, mature, wise, stable, change-resistant and risk and-averse…” That was then, but it did make me think when today I was once again reading through the WHO report “Health Technology Assessment of Medical Devices” how ambiguous this whole age perception is.

The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.

Useful, absent, useless or simply not up to modern communication and information exchange practices, finally I’ve just seen an honest debate on the thorny subject of instructions for use for medical devices. It seems that the seeds are being sown in the garden of England for future change to the benefit of everyone.