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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.
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.
eHealth is booming, hospitals, doctors, clinics, SMEs, big companies, everybody seems to be developing an app nowadays. It is great to see how many people are throwing their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of image interpreting software, decision support systems, …, you name it. […]
There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, […]
Posted on 08.02.2011
Recent events in Brussels are pointing to a fresh, healthy airing of views and more robust debate on the Recast. (By the way, I’ve noticed that everybody says ‘Recast’ but not too many people know what a ‘Recast’ is. So for all those legal and regulatory ‘techies’ among you, click here, all others steer clear!). […]
Posted on 17.12.2010
Yesterday, we, at Eucomed, had our Christmas party (Happy Christmas everybody and a big thank you to all the Eucomed members and staff for everything in 2010!!). And while thinking back at yesterday’s little get-together, it’s dawning on me that with 2011 just around the corner we will be just over two and half years since the original public consultation on the recast of the EU medical devices legislation.
Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time […]
Posted on 14.04.2009
Just back from Easter holidays and picked up this article from the Wall Street Journal “Medical Devices Face New Scrutiny From FDA”. When I read the article it reminded me again of one of the great untold strengths of device regulation in Europe and yet another example where the European system is better than the […]
From 23 – 25 March 2009, the Drug Information Association (DIA) held its annual EuroMeeting in Berlin. During the presentation by Richard Moore, Institute of Nanotechnology, I learned that prescription drugs prove to be ineffective in 30% – 60% of patients1 and that 16% of the drugs approved in the USA are linked to severe […]