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
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
UK MHRA Revamped Website!
The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a
COCIR Issues Flowchart to determine if Software = Med Dvc per MDD
COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment. The