A quick rehash of the changes outlined by EU commissioner for Health John Dalli in today’s press conference can be found by reviewing our simultaneous commentary here. The bottom line, if there is one, is that notified bodies will have far greater scrutiny of their activities and capabilities by a more active competent body involvement. Controls will be pan-European so no longer allowing softer interpretation in some countries than others. Expert panels will scrutinise approval requests and be involved earlier in the process than at the present time, and notified bodies will be mandated to do spot checks on manufacturers.
Oh and the big one as far as users of devices and patients, is that products and companies will be obliged to exist on a central database. While the exact contents of this database are not yet clear, it’s likely to include listings of approved devices, their regulatory status, possibly any details of alerts or adverse incidents, instructions for use (which would seem like a good idea if it happens) and maybe even clinical evidence used to gain approval, (which would be a great idea if it happens).
All sounding good so far?
Then consider one final element. Cost. One questioner raised the issue during today’s press conference and it was somewhat brushed under the carpet, but the reality is that there will be huge additional costs and these will almost certainly find their way to industry and consequently the purchaser. We predicted that some months ago, and we also predicted they wouldn’t go the whole way towards a U.S style PMA and would opt for heightened post-marketing surveillance.
What is staggering is that the only actual “product” to be mentioned in the press release and conference is the PIP breast implant, despite the fact that Mr Dalli went to great lengths to explain that that situation, being a seemingly deliberate fraudulent act, lay largely outside the regulatory legislation.
Overall then, a sensible raft of measures which strikes the sensible balance between protecting patient interests while maintaining a landscape in which it remains just about possible companies will remain motivated to innovate.