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
GHTF has transitioned to IMDRF
As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
EU Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations
On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active
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).
GHTF to morph into Int’l Med Dvc Regulators’ Forum (IMDRF)
The GHTF has been around for almost 20 years and is in the process of disbanding to become a more Regultor focused group called the International Medical Device Regulators’ Forum (IMDRF). In the Eucomed 18 Nov 2011 newsletter article they