Update to EU medical device vigilance guidance We wanted to let you know that the European MEDDEV 2.12.1 entitled "Guidelines on a Medical Devices Vigilance System" has been revised. Revision 6 includes minor “technical” modifications to the Incident Report Form, Annex 3. This has been revised to include the following:
- inserts query if the incident is serious public health threat;
- separates “death” from “unanticipated serious deterioration in state of health, serious public health threat” for classification of incident;
- includes one field for device manufacturing date and one field for expiry date, previously one field;
- adds implant and explant dates, for implants only; and,
- adds question about number of similar incidents.
The link to MEDDEV 2.12.1, REV 5 on the European Commission web site no longer functions. However, you can find and download the latest PDF version of MEDDEV 2.12-1 REV 6 in our Learning Library here:
http://www.emergogroup.com/resources/regulations-europe
There are also new references published in the Official Journal of European Communities for standards harmonized to the medical devices directives. The revised Annex 3 will be applicable starting 20 March 2010.
As always, we will keep you updated about changes to international medical device regulations as they occur.
Best Regards,
Evangeline Loh, PhD, RAC
Vice President of Regulatory Affairs
Emergo Group Inc.
P.S. If you would like to suggest a quality assurance or regulatory topic for us to address in a future issue of this newsletter, please reply to this email. |
