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dnaSRPS CEN/TR 17223:2017

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

General information

50.60     Jan 11, 2018

ISS

Z076

Technical Report

11.040.01     03.100.70  

Scope

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Life cycle

NOW

PROJECT
dnaSRPS CEN/TR 17223:2017
50.60 Close of voting. Proof returned by secretariat
Jan 11, 2018

Related project

Adopted from CEN/TR 17223:2018