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
Impact of the Draft report on the EU MDD proposed regulations
This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess
1 Step Closer to EU Medical Device e-Labeling
Per Eucomed’s 7 October 2011 newsletter electronic labeling of medical devices (MDD & AIMDD) has been approved as a draft regulation and is in the hands of “the Council and European Parliament who will have 3 months to exercise their