Post-Market Monitoring and Surveillance for Medical Devices in Norway

1. Manufacturer Obligations

Manufacturers of medical devices must establish a post-market surveillance system as part of their quality system. This system is designed to collect data on the medical device quality, safety, and performance throughout its lifecycle. The data is used to identify and implement preventive and corrective actions, ensuring the safety of the devices on the market. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

2. Requirements for Post-Market Surveillance

The post-market surveillance system should be based on a plan, and the manufacturer must prepare a report on surveillance of the device. The report's requirements depend on the device's risk class. Details about the requirements placed on the manufacturer for monitoring the devices can be found in MDR Art. 83-86 / IVDR Art. 78-81, and Annex III. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

3. Post-Market Surveillance Plan

This plan includes information on collecting and using data related to serious incidents and user complaints. Specific requirements are outlined in Annex III, Section 1. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

4. Report on Post-Market Surveillance for Lower-Risk Devices

Applicable to Class I medical devices and in vitro diagnostic medical devices in Class A and B. The report should summarize surveillance results and conclusions, justify and describe preventive and corrective measures, and be updated as needed. It should be made available to the Norwegian Medical Products Agency upon request. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

5. Periodic Safety Update Report (PSUR) for Higher-Risk Devices

Applies to Class IIa, IIb, and III medical devices, and in vitro diagnostic medical devices in Class C and D. The report should summarize surveillance results and conclusions, justify and describe preventive and corrective measures, and be updated periodically based on the device's class. It should be accessible to the notified body involved in conformity assessment and the Norwegian Medical Products Agency upon request. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

6. Relevant EU Guidance

The European Commission and MDCG publish guidance documents on medical devices. Currently, MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 is published. Post-Market Surveillance requirements guidance is under development. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

7. Relevant EU Regulations

• MDR - Regulation (EU) 2017/745 on medical devices
• IVDR - Regulation (EU) 2017/746 on in vitro diagnostic medical devices Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market

8. Contact Information

Unit for medical devices - market surveillance
(+47) 22 89 77 00
Medical device vigilance
msod@noma.no Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/monitoring-after-device-is-placed-on-the-market