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MDR Technical Documentation

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Guest user Created:   Feb 15, 2021 Last commented:   Feb 16, 2021

MDR Technical Documentation

1. Is it acceptable under MDR to have Technical Documentation for medical device families rather than for every individual medical device?

2. Is it acceptable under MDR to group medical device families based on the basic design and performance characteristics related to safety, intended use and function as defined in ISO 13485:2016?

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 16, 2021

According to the definitions in the ISO 13485:2016, a medical device family is a group of medical devices manufactured by or for the same organization and have the same basic design and performance characteristics related to safety, intended use, and function. You can have one Technical documentation for the group of the medical devices with a complete list of the various configurations/variants. 

To see how to structure the Technical file according to MDR, see this Technical file template: https://advisera.com/13485academy/documentation/technical-file-template/

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Feb 16, 2021