Guidelines
According to Article 86 of the MDR, the Periodic Safety Update Report (PSUR) is a new regulatory requirement applicable to Class IIa, IIb, and Class III devices.
Lower risk class I devices require a Post Market Surveillance Report (PMSR). At a minimum, class IIb and class III PSURs should be updated annually, and throughout the lifecycle of the device. Class IIa PSURs must be updated when necessary, and at least every two years. The PSUR forms part of the technical documentation as outlined in Annexes II and III of the MDR.
Manufacturers of class III or implantable devices must submit their PSURs to their notified body via Eudamed. The notified body will review the content and provide an evaluation of the report. Both the PSUR and the notified body evaluation will then be available to competent authorities via Eudamed.
Manufacturers of class IIa and class IIb devices are not required to upload their PSUR to Eudamed, but the report must be made available to their notified body, and competent authorities upon request.
PSUR inputs include, but are not limited to:
- Complaints,
- Non-conformances,
- CAPAs,
- Field Safety Corrective Actions,
- Literature searches related to the subject device,
- Literature searches related to equivalent or similar devices,
- Vigilance database searches related to similar devices,
- The outcome of trend analysis,
- The outcome of benefit-risk analysis.
The establishment of robust post-market surveillance, vigilance, and risk management processes will facilitate the seamless creation of the PSUR. The data inputs should be reviewed regularly, at defined intervals, so that nothing unexpected arises when the time comes to compile the data into the PSUR.
MDCG 2022-21 should be consulted for detailed guidance on compilation of the PSUR.