In the LinkedIn Group – BSI Standards Network – there was this question on 6 Nov ’12: “Does anyone in the group know when the IEC 60601-1-1:2005 +A1:2012 is likely to get turned into a EN by Cenelec?”
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
Update on National Implementations of IEC 60601-1:2005
This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition. It is the top article on our Featured Articles WebPage. This article is on the National Implementations of
NB-MED issues V1.1 FAQ on Implementation of EN60601-1:2006 w.r.t. MDD
6 Feb 2012 – The NB-MED EN60601-1:2006 issues team released their first official version (V1.1) of this important implementation document in regards to EN 60601-1 with respect to the Medical Device Directive 93/42/EEC (primarily written for this directive) and also