How to report a serious incident
Manufacturers must report serious incidents immediately after a causal relationship between the incident and the medical device has been established or when such a causal relationship is reasonably assumed.
Until the European medical device database, Eudamed, is fully operational, the serious incident should only be reported in the country where the incident occurred. The report should be sent to the competent authority of that country, which in Norway is the Norwegian Medicines Agency.
The deadline applies from the date the manufacturer became aware of the incident until the report is sent to the authorities.
If there is uncertainty about whether the incident is reportable to the authorities, it should still be reported within the deadlines.
|Classification of incident||Deadline|
|Serious threat to public health||2 days|
|Unexpected serious deterioration of a person's health condition||10 days|
|Other serious incidents||15 days|
If the manufacturer has all the necessary information to conclude within the deadlines, the report can be submitted as a combined preliminary and final report (combined report). If it is not possible to determine if an incident is reportable, it should be reported within the deadlines. The manufacturer can choose to submit a preliminary but incomplete report and then follow up with a complete report once all necessary information has been obtained and the investigation has been completed.
For reporting to the authorities, the common European reporting form, Manufacturer Incident Report (MIR), should be used.
Upon submitting a preliminary report, the Norwegian Medicines Agency will respond with their case number. This number should be clearly stated in all further communication.
For more information about the different fields, refer to the support document MIR helptext.
The completed reporting form should be sent to:
Both PDF and XML versions of the report should be attached.
Mandatory reporting for Healthcare Facilities
Healthcare facilities are obligated to report serious incidents that have or may have a connection with the use of medical equipment.
Healthcare facilities report on melde.no
If you, as a private individual, experience a serious incident with a medical device, you are encouraged to contact a healthcare provider, distributor, or others from whom you obtained the specific equipment. They are obliged to report further.
Overview of the different roles of economic operators:
Definition in MDR Article 2 and IVDR Article 2
|Manufacturer||A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.|
|Authorised representative||Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.|
|Importer||Any natural or legal person established within the Union* that places a device from a third country on the Union* market.|
|Distributor||Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.|
|Health institution||An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.|