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 has never been compulsory. Hence its use by EU authorities has been patchy – to say the least.
All going well the obligatory use of Eudamed will apply from 1 May 2011 and certain existing data will need to be entered by 30 April 2012.
So what does it all mean? And is it of any use?
To see the importance of Eudamed, let’s deal with those questions in reverse.
Eudamed was first conceived in 1998 as a ‘good idea’ to help in sharing data between authorities on problems with devices in the EU market. Unfortunately the idea of Eudamed was overtaken in terms of need and undertaken in terms of law.
Today the type and amount of data that all stakeholders see as useful (I won’t go into the hot debate on the ‘amount’ here) is far greater than conceived in 1998. Then, it was simple details on adverse events and details on national registrations, if available. Today all agree that we need to know a lot more besides, not least information that should be available to the patient.
But most significantly, and this is the ‘law’ bit, there are two fundamental problems. Legally, Eudamed is only accessible to Member State authorities and, again legally, it does not replace national registration databases.
This creates the problem that neither the public nor doctors know any useful information about that device, not least whether or not a medical device is legally on the market in the EU. The second issue is that, even with Eudamed in place, manufacturers have to continue to undergo a typically Eurocratic nonsense of registering their product a potential 27 times or more around Europe! Imagine having to stop and register your car in each member state as you drive across Europe on your holidays. Manufacturers don’t just have to do this every summer but every week. Surely the stuff of EU history! But no, this situation exists today and until this quirky piece of ‘anti-internal market’ legislation is cleared away we will continue to waste time and money with no resultant patient benefit.
Thankfully sanity seems to be prevailing and the Commission and Member States seem to agree that we need to solve this in patients, doctors and industry’s interests and that this will be solved when the medical devices Directives are revised in 2010.
So should we be happy with Eudamed? The answer should be a resounding YES! It is the first legally certain step in the right direction. All we need to do now is make sure that there is a second step.
– John Brennan, Eucomed Director Regulatory and Technical Affairs