Manufacturers, authorised representatives, importers, distributors, users and owners of medical devices are all obliged to report on serious incident caused by medical devices. A serious incident means any incident that directly or indirectly led, might have led or might lead to the death of a patient user or other person, the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, or a serious public health threat.
When in doubt if there is an obligation to report an incident, the Norwegian Medicines Agency strongly encourages all relevant parties to submit a report. The manufacturer is obligated to perform the necessary investigations in relation to the serious incident and the devices concerned.
The use of a medical device shall be conducted in accordance with the instructions for use. Off-label use of a medical device may make the user legally responsible for the device.
Users and owners
Users and owners of medical devices are obligated to report serious incidents to the Norwegian Medicines Agency. Users and owners of medical devices may report incidents on Melde.no.
Manufacturers and authorised representatives
Manufactures and authorised representatives must report serious incidents and field safety corrective actions in accordance with MDR article 87 and IVDR article 82. Please use the European Union forms Manufacturers Incident Report (MIR) and Field Safety Corrective Action (FSCA).
The forms may be submitted by email to email@example.com.
Importers and distribtuors
MDR and IVDR article 13 and 14 state the general obligations of importers and distributors of medical devices.