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 medisinsk.utstyr@legemiddelverket.no. ​

Legal requirements for the obligation to report adverse incidents

The obligation to report adverse incidents is regulated by:

• Act of 12 January 1995 no 6 on medical devices § 11
• Regulations of 15 December 2005 no 1690 on medical devices § 2-11
• Regulation of 29 November 2013 no 1373 on use of medical devices § 16)
• The guideline on a medical devices vigilance system (MEDDEV 2.12/1) from the EU-commission for manufacturers and competent authorities is also followed by Norwegian authorities

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The Norwegian Medicines Agency may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref.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.

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