ISO 13485:2016 , regulatory requirements

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: 

• EU MDR Article 8 –Use of harmonized standards https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

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:

• EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• EU MDR Article 15 – Person responsible for regulatory complaince https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/