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ISO 13485:2016 , regulatory requirements

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Guest user Created:   Mar 18, 2021 Last commented:   Mar 19, 2021

ISO 13485:2016 , regulatory requirements

I would be interested in the process of meeting the regulatory requirements according to ISO 13485:2016. What are the mandatory documents ? How to handle the review process for all standards/ legislation and other regulatory documents in the company ?

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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 Mar 19, 2021

According to Article 8 of the MDR, all medical device manufacturers need to be in compliance with standards published in the Official Journal of the European Union. On this list, there are more than 300 different standards for all kinds of medical devices. Each manufacturer must define to which standards it must comply.

For more information, see: 

According to Article 15 of the MDR, manufacturers need to nominate at least one person that will be responsible for the regulatory compliance. Furthermore, in Article 10, point 9, it is necessary that as part of the quality management system, there is a document where the strategy for regulatory compliance will be described. This document will describe how often the review process for all standards/ legislation will be conducted (for example will it be every month, every 3 months, or longer period). And also, if there will be a new revision of the standard/legislation what must be done (GAP analysis, new tests, new reports, is there a necessity for education or some other resources).

For more information, see:

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