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 medisinsk.utstyr@legemiddelverket.no. 

See Norwegian guidelines for the obligations to report (PDF) for detailed information on who is to notify, what should be reported, and how the report should be given.

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The Norwegian Medicines Agency may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref.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