“To devise a regulatory system solely about this particular event would be to miss the point that most of the problems that arise around medical devices are of a very different nature to this.”
European medical device industry body Eucomed has reported the views of Professor Sir Kent Woods of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA).
Professor Woods has called for a careful and considered approach to medical device regulatory reform, according to several press reports. Speaking at a briefing, Sir Kent said that improvements should be made to the current system but warned that a case like that of Poly Implant Prothèse (PIP) should not inspire a knee-jerk reaction.
The PIP incident, according to Sir Kent, is a rare and unusual one of “manufacturing fraud” and not the result of a flawed regulatory framework. Instead of drastic changes and a shift toward centralisation, regulators in the European Union’s 27 Member States should work to increase co-ordination. Stepped-up surveillance and reporting of medical device flaws would also serve to improve the EU’s medical device safety record.
“Clearly one does not in any sense get complacent about events such as this” Sir Kent told those in attendance, “but recognise though that they are exceedingly rare. To devise a regulatory system solely about this particular event would be to miss the point that most of the problems that arise around medical devices are of a very different nature to this.”
Sir Kent also made clear the enormity of Europe’s regulatory challenge with 17,000 medical device manufacturers in Europe alone. “You can have a regulatory system, but actually you can’t promise to stop people breaking regulations. There has to be, at the end of the day, a degree of trust in the system but it has to be backed up by the very best healthcare regulation that you can get”.
Source: Eucomed: What’s New? March 2nd 2012
published: March 5, 2012 in: Regulatory