The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of
White Paper on Proposed New EU Medical Device Regulations
The Emergo Group issued a White Paper on 22 October 2012 in regard to the 26 September 2012 Proposed New Medical Device Regulations for Europe (this weblink brings you to the “Medical Devices – Ongoing Revisions” page of the EUROPA website).