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Update to EU medical device vigilance guidance


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: https://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.

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