ForsideEnglishMedical devicesReporting of adverse incidents involving medical devices Reporting of adverse incidents involving medical devices Incidents with medical devices on the market, as well as injuries, accidents and failures where medical devices is or may have been involved, shall be reported to the Norwegian Medicines Agency. SideinnholdNotification form for manufacturer, authorised representative and distributorManufacturer 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 incidentsThe obligation to report adverse incidents is regulated by: Act of 12 January 1995 no 6 on medical devices § 11Regulations of 15 December 2005 no 1690 on medical devices § 2-11Regulation 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 authoritiesThe 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applies regardless of injury to a person.The Norwegian Medicines Agency may in some cases claim a medical device to be withdrawn from the market, to prohibit or restrict the right of placing on the market or use/application of a medical device, ref.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 Fant du det du lette etter? Ja Ja Nei Nei Så bra! Hva var det du lette etter på denne siden? Kan du fortelle hva du ikke fant? Vennligst ikke oppgi navn eller kontaktinformasjon i dette feltet, men send oss en e-post hvis du har konkrete spørsmål. Send inn tilbakemelding Skriv ut