Module 16 2024

17/10/2024

What are the post-market surveillance requirements of the MDR?

• Article 83, Post-market surveillance system of the manufacturer

3) Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

e) for the identification of needs for preventive, corrective or field safety corrective action;

PMS data is used to identify the need for corrective/preventative action.

© NAMSA 2023 | 21

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What are the post-market surveillance requirements of the MDR?

• Article 83, Post-market surveillance system of the manufacturer

3) Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

f) for the identification of options to improve the usability, performance and safety of the device;

PMS data is used to improve usability, performance and safety.

© NAMSA 2023 | 22

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