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Periodic Safety Update Report (PSUR)

Preparation and content of periodic safety update reports.

Official catalogue · non-binding

Periodic Safety Update Report (PSUR) guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
December 2022
Topics

Source document

  • MDCG 2022-21PDF · Unverified extraction previewOfficial source

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