Module 16 2024

24/10/2024

Draft PMS SI Summary

Requirements similar to EU Regulations

Implementation of PMS SI expected in early 2025?

Manufacturers will be required to maintain a post-market surveillance system for each device, analyze relevant data, report serious incidents, and take necessary preventive and corrective actions. ​

Guidance required to provide more detail on specific requirements

Manufacturers will need to implement field safety corrective actions and issue field safety notices when necessary. ​

Manufacturers will have to produce a periodic safety update report (PSUR) for each device.

The PSUR must include a summary of post-market surveillance plan results, description of preventive or corrective actions, required risk analysis, conclusions of post-market clinical follow-up, and device usage information.

More AB involvement in PMS & V

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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A book cover of a medical application guide

Description automatically generated

Thank you Website • UKCA for Medical Devices | TÜV SÜD (tuvsud.com)

Email

• mhsuk@tuvsud.com

• TUV SUD BABT Medical Devices Application Guide

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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