Module 16 2024

18/10/2024

Preparing a PSUR

We can see that the MDR is clear on what inputs need to be covered, when developing a PSUR…however…..this does not make this an easy process.

• The MDR places the emphasis on the following:

➢ Handling of appropriate “data” and turning it into “information”

➢ Using appropriate methods and processes…

➢ Systematic procedures and effective tools…

To prepare sound PMS reports and PSURs, manufacturers need to make sure to embed these requirements into a sound PMS process that turns “data” into “information”. …..a documented procedure (and a template for PSURs) that captures this process needs to be in place.

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Preparing a PSUR – MDCG 2022-21

An MDCG document provides guidance on PSURs – MDCG 2022-21 (Dec. 2022).

- For manufacturers, no guidance for notified bodies.

- Information on:

- Content

- Duration of PSUR

- Device grouping

Various annexes, including templates for the presentation and assessment of collected data (Annex II & III) and for the PSUR itself (Annex I)

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