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CEI CEN/TR 17223 : 2019

Current
Current

The latest, up-to-date edition.

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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-05-2019

This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.

Committee
CT 62
DocumentType
Technical Report
Pages
0
PublisherName
Comitato Elettrotecnico Italiano
Status
Current

Standards Relationship
CEN/TR 17223:2018 Identical

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£158.61
Excluding VAT

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