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PD CEN/TR 17223:2018

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

03-21-2018

Publisher

British Standards Institution

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.

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.

Committee
CH/210
DocumentType
Standard
ISBN
9780580519123
Pages
88
PublisherName
British Standards Institution
Status
Current

Standards Relationship
CEN/TR 17223:2018 Identical

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Hardcopy - English
PDF - English
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