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Eucomed has recently submitted remote monitoring of implantable cardiac devices as one of its four proposals to the Active and Healthy Ageing Innovation Partnership under the European Commission’s Innovation Union Strategy. Such an initiative is exactly what Europe is in need of to ensure its place at the top of the innovation ladder. Eucomed selected […]

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, […]

The recent report from the European Commission into the reuse of single use medical devices reminds me of Hamlet. The Danish prince, like the Commission in their report, had to contemplate the nature of action, and whether to suffer The slings and arrows of outrageous fortune, Or to take arms against a sea of troubles […]

Patient safety and public perception: transparency, transparency, transparency…In scanning the disparate output of the EU machine I came across a thought provoking survey of EU citizens on the subject of patient safety. Perception surveys are scientifically questionable as  they deal in the currency of (often poorly informed) individual’s views. Politically and from a policy perspective […]

On the 29th October all the votes were in and it seems that nothing more than EU paperwork stands between us and our first compulsory European database for medical devices, the infamous ‘Eudamed’ database. I say compulsory because ‘Eudamed’, as our European device database is known, has been in place for many years, but it […]

Returning to the daily routine after a long, and hot, summer break is always characterised by mixed feelings. Part wishes the languorous morning routines to carry on whilst other forces bring a refreshed mind optimistic about the challenges ahead. This morning’s bright and early start in Brussels was illuminated by two articles in the Financial […]

Listening to a distinguished panel of experts chaired by Bernard Merkel of DG Sanco I get the impression that things are moving to raise the level of patient safety. I was interested to learn that DG Sanco has commissioned a study to rate Member States in their efforts to combat patient safety. This “black list” […]

The sweltering heat and fever pitch of the football supporters contrasts starkly with the measured debate at the 2009 International Medical Device Industry Compliance, Regulatory and Intellectual Property Conference here in Rome. The Champions League final sees football shirted supporters rubbing shoulders with suited captains of industry in an unlikely melange. One item of news […]

Just sitting at the airport after what was an excellent Global Harmonization Task Force Conference. Well done Steve Dibert and his crew, not to mention Health Canada. Who says regulatory affairs is boring! This conference really put the moose among the pigeons! We had a truly gripping opening session from Dr. Robert Jackson, the renowned […]