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.
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.
Casus transposed the PDF Annexes of MDCG 2022-21 into word format and made them available here for download. The main PSUR template combines all Annexes into a single document, plus additional help text for the user. Each individual MDCG 2022-21 Annex has also been made available for 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