Module 15 2022

19/05/2022

Periodic safety update report (PSUR)

• MDCG guidance is not currently available • Draft guidance includes: • PSUR is a summary of the findings from PMS, PMCF and Clinical Evaluation

• Requires the use of IMDRF medical device problem codes • Emphasis on risk evaluation and links to risk management • Must conclude that the benefit continues to outweigh the risks

• Provides example schedules, gives consideration to literatures searches, clinical evaluation report updates, PMS/PMCF reports, data-lock and issuing of the PSUR • The data lock is on the anniversary of the CE certificate, expects PSUR to be published within 90 days

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

27

Periodic safety update report (PSUR)

• Grouping of devices in a single PSUR is permitted under the following circumstances: • The devices are combined to achieve a common intended medical purpose, or • Equivalence is demonstrated for the devices grouped, or • A case-by-case agreement with the Notified Body or Competent Authority • The grouping may be justified for custom-made devices based on the same intended purpose, materials used, processes utilized, and the same principal design

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

28

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