Notification form for manufacturer, authorised representative and distributor

Manufacturer Incident Report MIR (ec.europa.eu)

(In Guidance MEDDEVs under 2.12 Market surveillance)

The completed form should be send by e-mail to medisinsk.utstyr@helsedir.no 

See Norwegian guidelines for the obligations to report (PDF, in Norwegian) 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:

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

The Norwegian Directorate of Health and Norwegian Directorate for Civil Protection (DSB) may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref.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.

Sist faglig oppdatert: 1. september 2016

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