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
EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go
Electronic IFUs for EU MDD & AIMDD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012. Here’s a general summary: The directive does not cover
Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC 60601-1 & related 60601 Series of Stds
Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS
EC asks for further scientific study & draws 1st lessons from recent fraud on breast implants
From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below. The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further