Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex III technical documentation on post market surveillance, including:

Worldwide and EU sales volumes.

Complaint data and trend analysis.

Market History.

Modifications made and/or corrective actions taken following the incidents reported and revisions

Vigilance data and trend analysis (include details of any adverse incidents, recalls or FSCA)

Publicly available information about similar medical devices.

made to the risk management file.

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex III technical documentation on post market surveillance, main headings

A PSUR template for IVD’s should be available soon from the MDCG but in the meantime manufacturers could use the guidance for devices (MDCG 2022-21).

2. The PSUR referred to in Article 81 and the post

market surveillance report referred to in Article 80.

The Organisation for Professionals in Regulatory Affairs

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