Notification form for manufacturer, authorised representative and distributor
Manufacturer Incident Report MIR
(In Guidance MEDDEVs under 2.12 Market surveillance)
The completed form should be sent by e-mail to email@example.com.
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The Norwegian Medicines Agency may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref.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.