Module 16 2024

18/10/2024

Preparing a PSUR

MDCG 2022-21: Annex I: Template for the PSUR

PSUR cover page

Executive summary

Description of the devices covered by the PSUR and their intended uses (Article 86.1)

Grouping of the Devices

Volume of Sales (Article 86.1)

Size and other characteristics of the population using the device (Article 86.1)

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Preparing a PSUR

MDCG 2022-21: Annex I: Template for the PSUR

Post-Market Surveillance : Vigilance and CAPA information a) Information concerning Serious Incidents (Article 87, Annex III MDR) b) Information from Trend Reporting (Article 88, Annex III MDR, non-serious incidents and expected undesirable side effects) c) Information from Field Safety Corrective Actions (FSCA) (Article 87, Annex II MDR) d) Preventive and / or Corrective Actions (CAPA) (Article 83.4 and Article 86 MDR) Post-Market Surveillance: information including general Post-Market Clinical Follow-up (PMCF) information (Annex III and Annex XIV, Part B, 6.2(a) and (f) MDR) a) Feedbacks and complaints from users, distributors and importers b) Scientific Literature Review of relevant specialist or technical literature c) Public Databases and /or Registry Data d) Publicly Available Information about Similar Medical Devices e) Other Data Sources Specific Post-Market Clinical Follow-up (PMCF) Information (Article 86, MDR Annex XIV, Part B, 6.2(b))

Summary of Findings and Conclusions of the PSUR a) Validity of the collected data b) Overall conclusions from the analysis of the collected data c) Actions taken by the manufacturer

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