Module 16 2022

9/2/2022

Challenges selecting inputs for PSUR

• This means that in order to prepare sound PMS reports and PSURs, the manufacturer will need to make sure to embed these requirements into a sound PMS process that turns “data” into “information”. • Also, a documented procedure (and a document boiler template for PSURs) that captures this process needs to be in place…

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© NAMSA 2021

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Challenges selecting inputs for PSUR

Lay Persons

It should be noted at this time there is no formal guidance on the format or content of a PSUR via a MDCG guidance document. Draft guidance has been produced which is used as reference by some Notified Bodies but the formal publishing of the guidance has now been delayed twice. This would indicate that there a number of areas of the draft guidance which are a point of concern. Therefore until formal guidance is published the requirements for PSURs cannot be definitively defined.

Protection against risk

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© NAMSA 2021

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