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 […]

In an ideal world we would have the same rules on devices in each country.  As patients, as we live or travel in different countries, we can be confident that should we fall ill, the devices used to help us are as safe as the ones at home.  As businesses, we would be confident that […]

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 […]

I put it down to Irish politeness to always say “no” first when asked if we want something and to follow up with a “yes” when asked the second time. “Will you have a cup of Lisbon tea?Oh no thank you, I’ve had quite enough already.Are you sure? I’ve just made some and I can […]

An interesting article in the latest issue of Clinica.  David Nicolson, the CEO of the UK’s National Health Service (NHS) speaking at the Innovation Expo meeting stressed the importance of investing in innovation for long-term benefits and warned the NHS against isolating itself and becoming risk-averse.Clearly the what Eucomed has been alerting policy makers to […]

A crowded room at the offices of the European Policy Center yesterday afternoon. The topic of the day is “The future of medical devices in Europe”. The distinguished panel includes Josée Hansen, Pharm. D, project leader, Priority Medical Devices/ EHT, WHO-Geneva . Ms Hansen elaborated on the project’s approach, scope and objectives. In a nutshell, […]

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 […]

Sitting in the crowded main conference hall of Berlin International Congress Center (ICC) on the opening day of Germany’s largest health policy conference, the so-called Hauptstadtkongress, I am keen to see where senior government officials see the healthcare system headed. The conference center breathes the atmosphere of a 70s sci-fi movie. I am listening to […]

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 […]