Module 16 2024

17/10/2024

The post market surveillance plan

12) Post-market surveillance reporting

Article 85 (PMS Report)

Article 86 (PSUR)

Annex III, 1.2 - The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85

PMS procedure – details the reporting processes (PMS report, PSUR)

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The post market surveillance plan

13) Technical documentation maintenance:

Article 83, 3 - Data gathered from PMS shall be used to:

a) Update the benefit/risk determination and improve risk management b) Updated design/manufacturing info; the IFU and labeling c) Update the clinical evaluation d) Update the SSCP e) Identify the need for CAPA f) Identify options to improve usability, performance, safety g) Contribute to surveillance of other devices h) To detect and report trends

Technical documentation procedure – details the maintenance of technical documentation

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