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Requirement for Post Market Surveillance

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Guest user Created:   May 11, 2021 Last commented:   May 11, 2021

Requirement for Post Market Surveillance

We manufacturer Class 1 medical devices and I am wondering what we are required for the Post Market Surveillance procedure?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 11, 2021

According to Article 83 - Post-market surveillance system of the manufacturer - is stated that for each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. Then, in Article 85 - Post-market surveillance report - Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan.

Therefore, class I medical devices are not exempt from the post-market surveillance system.

More information on the Post-market surveillance system you can find on the following link:

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May 11, 2021

May 11, 2021

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