As usual, medico-legal specialist Erik Vollebregt doesn't mince words on his blog post about the much-debated scrutiny procedure in the proposed medical device regulations. Just returning from MedTech Forum, which was held in Brussels from 10 to 12 October 2012, Vollebregt considers "S is for scrutiny, which we’re not sure about" as the takeaway message from the meeting.
Vollebregt regrets that industry may be forced to accept a premarket authorisation type component in the regulations "based on the misconception that devices are regulated like toasters." A big surprise for Vollebregt was a representative from the European Society of Cardiology stating that the organisation is "not in favour of a PMA type system after all, because of the detrimental effects on innovation and R&D. Too little, too late and thanks for helping to create all this confusion," writes Vollebregt.
There's much more on the medicaldeviceslegal blog, and much more to come, as Vollebregt promises to write about the specifics of the proposed regulation in the weeks and months ahead.
For more about the scrutiny procedure: EC’s Proposed Scrutiny Procedure Will Not Improve Patient Safety but Could Harm Industry.