Module 16 2024

17/10/2024

The post market surveillance plan

• PMS plan scope and objectives:

The results of the plan shall be used to:

Article 83, 3(e) - Identify the need for preventive, corrective, or field safety corrective action;

Article 83, 3(f) - Identify options to improve the usability, performance, and safety of the device;

Article 83, 3(g) - When relevant, contribute to the post-market surveillance of other devices;

Article 83, 3(h) - Detect and report trends per Article 88.

© NAMSA 2023 | 41

41

The post market surveillance plan

• Assign responsibilities:

Article 15

Article 83, 3 - The PRRC or a delegate is responsible for analyzing the results of the PMS plan and ensuring the technical documentation is updated accordingly.

Article 84, 4 - The PRRC or a delegate is responsible for initiating and following up on corrective or preventative action undertaken due to the findings of PMS.

© NAMSA 2023 | 42

42

21