Module 19 2021

24/05/2021

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

1. The post-market surveillance plan drawn up in accordance with Article 79. Comment: – Requires ‘publicly-available information about similar medical devices’ – Specifies minimum requirements for post-market surveillance plan – Requires a PMPF plan, or ‘a justification as to why a PMPF is not applicable’. The IVDR does not specify when PMPF is not applicable.

The Organisation for Professionals in Regulatory Affairs

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

2. ‘The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.’ A PSUR template is still awaited from the MDCG but in the absence of which manufacturers may have to generate their own versions.

The Organisation for Professionals in Regulatory Affairs

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