Periodic Safety Update Report Template

A Periodic Safety Update Report (PSUR) is the evaluation of a device’s post-market surveillance data. The PSUR is intended to help the manufacturer systematically, and regularly, assess the medical device’s risk-benefit ratio.

Manufacturers are required to compile a PSUR for their Class IIa, IIb and III devices. This requirement is not only for MDR CE marked devices; ‘legacy’ MDD/AIMDD CE marked and custom-made devices also require a PSUR.

The Medical Device Coordination Group issued a guidance document for PSURs. Annex I, II, III and V of MDCG 2022-21 include a PSUR template available for use. However, the template is provided in PDF format, requiring that each manufacturer recreate it if they want to make use of it.

Casus transposed the PDF Annexes into word format and made them available here for download. The main PSUR template combines all Annexes into a single document and includes additional helpful text for the user. Each MDCG 2022-21 Annex has also been made available for individual download. All documents are fully editable.

For more information regarding how often a PSUR must be generated, which PSURs must be provided to the Notified Body, how to bundle products for a PSUR, and more, please read: MDCG 2022-21: Guidance on Periodic Safety Update Reports

PSUR Templates - MDCG 2022-21

  PSUR Template – Combined

   PSUR Template – ANNEX I

  PSUR Template – ANNEX II

   PSUR Template – ANNEX III

  PSUR Template – ANNEX V