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  CEN/TR 17223:2018 Issued

A new technical report from CEN is an invaluable tool for EU-MDR and EU-MDR implementation. It provides a cross reference between the requirements of the new regulations and the clauses of ISO 13481:2016. The technical report has two extensive tables, one for each regulation. The tables start with the specific requirements in the articles, follows them through the annexes, identifies the applicable clauses of ISO 13485:2016, and offers a conclusion on the coverage.

 

CEN/TR 17223:2018 Guidance on The Relationship Between EN ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

 

 

 
 
 
 
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