CEI CEN/TR 17223 : 2019
Current
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
05-01-2019
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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