Notification form for manufacturer, authorised representative and distributor

Manufacturer Inciden​t Report MIR

(In Guidance MEDDEVs under 2.12 Market surveillance)

The completed form should be sent by e-mail to ​

Legal requirements for the obligation to report adverse incidents

The obligation to report adverse incidents is regulated by:

The obligation to report adverse incidents applies regardless of injury to a person.

The Norwegian Medicines Agency may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref. Regulations of 15 December 2005 no 1690 on medical devices § 6-4.

Publisert: 19.12.2017

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