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:

a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;

Post-market data must be fed back into the risk-evaluation, including new hazards, and real-world severity and occurrence rates for existing hazard.

Risk evaluation is a continuous process throughout the device’s life cycle.

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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:

b) to update the design and manufacturing information, the instructions for use and the labelling;

PMS data will identify design and manufacturing issues that need to be resolved.

PMS will identify usability issues that need to be communicated.

PMS drives corrective/preventative action.

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