On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home
When will IEC 60601-1:05+A1:12 turn into EN Standard?
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
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).