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:

g) when relevant, to contribute to the post-market surveillance of other devices; and

PMS data from one device may be relevant to devices of the same generic group or having a same/similar design or using the same/similar manufacturing processes.

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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:

h) to detect and report trends in accordance with Article 88.

PMS systems must support trending of complaints, undesirable side effects, incidents, and serious incidents.

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