Module 16 2024

18/10/2024

PSUR embedded in the PMS and CER

Technical documentation (TD) on PMS to be drawn up in accordance with Articles 83 to 86.

To be presented in a “ clear, organised, readily searchable and unambiguous manner ”….. shall include in particular the elements described in Annex III.

Annex III consists of two sections:

(1) Content of the post-market surveillance plan (article 84);

(2) Reference towards PSUR (Article 86) and PMS reports (Article 85).

NOTE: Annex VII identifies requirements towards Notified Bodies during QMS audits and TD assessments. PMS requirements are mentioned. Annex IX identifies QMS requirements for the PMS system

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PSUR embedded in the PMS and CER

PSUR should capture the results and conclusions of the analyses of the PMS data gathered by the PMS Plan as well as:

a) the conclusions of the benefit-risk determination;

b) the main findings of the PMCF; and

c) the volume of sales (by region) of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Requires a close connection between the PMS process, the CER and Risk Management to process this data in a reliable and chronological manner.

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