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 US system.
Devices in Europe have always had to have clinical safety data at their back. Manufacturers selling in Europe have always had to establish the clinical evidence that supported the safety and performance of their devices. As the article in the Wall Street Journal states, US devices used the “less rigorous [sic]” 510K system, and only have to show “substantial equivalence”, the so-called ‘me-too’ approach.
I always had my doubts about the ‘me-too’ approach. I could never understand how a manufacturer could be so sure that his device was the same or similar to his competitors. Surely such an approach would require (illegal?) access to proprietary information from your competitor. Anyway, it seems that the Americans are catching up and that can’t be a bad thing.
One positive here is that any manufacturer who also sells in Europe will be at an advantage as they already have data; although this brings up the old chestnut as to the difference between ‘safety and performance’ (EU) and ‘safety and effectiveness’ (US) – but that’s a post for another day.
Cheers for now,
– John Brennan, Director Regulatory and Technical Affairs, Eucomed