Monitoring after device is placed on the market
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 equipment's 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.
Requirements for Post-Market Surveillance
The post-market surveillance system should be based on a plan, and the manufacturer must prepare a report on equipment surveillance. 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 Attachment III. Below, we have provided the main content of the articles related to the surveillance plan and post-surveillance report
Post-Market Surveillance Plan
This plan includes information on collecting and using data related to serious equipment incidents and user complaints. Specific requirements are outlined in Attachment III, Section 1.
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 Medicines Agency upon request.
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 Medicines Agency upon request.
Relevant EU Guidance Documents
The European Commission and MDCG publish guidance documents on medical devices. Currently, guidance related to market and safety surveillance is being developed:
Periodic Safety Update Report requirements
Post-Market Surveillance requirements