The UK Commons Health Select Committee has been in session to discuss the PIP scandal. BBC has followed the item here, but of most note is the comment from Professor Sir Kent Woods, Chief Executive of the Medicines and Healthcare Products Regulatory Agency (MHRA) who said the system of registering medical devices in Europe generally worked well, but attention needed to be paid to the issue of spot checks of manufacturers.
Again, we at medlatest concur. There is no doubt in our collective minds that the EU Medical Devices Directive(MDD) works well in most cases and is a pragmatic control on devices being used by clinicians on a daily basis. But it cannot be a completely benign tool with notified bodies acting like consultants on regulatory matters which may require interpretation. That’s what quality and regulatory managers and consultants are supposed to do.
MDD needs (and is getting) a degree of reform and this issue of unannounced spot checks is on the list. Followed closely we hope by treatment of the conflict of interest that is the relationship between a company and its notified body.
No doubt we’ll return to this subject.