PD CEN/TR 17223:2018
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
Hardcopy , PDF
English
21-03-2018
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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 |
CH/210
|
| DocumentType |
Standard
|
| ISBN |
9780580519123
|
| Pages |
88
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| Standards | Relationship |
| CEN/TR 17223:2018 | Identical |
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