Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

Name: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: eu,european-union,guidances,mdcg,pms,post-market,post-market-surveillance,regulations,reporting,safety,surveillance,updates,vigilance

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Post-Market Surveillance And Vigilance (PMSV)

Published

December 1, 2022

Last updated

December 1, 2022

Description

Get guidance on Periodic Safety Update Reports (PSUR) as per EU Regulation (EU) 2017/745, covering Post-Market Surveillance and Vigilance (PMSV).

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

Suggest an improvement to this page

1 Main file

MDCG 2022-21

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/6e324a50-5273-4df6-8fe4-c887db0fb760
MIME Type: application/pdf

Created on: September 6, 2023
Modified on: September 6, 2023