NEN NPR 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
Published date
04-10-2018
Publisher
Gives 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.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| CEN/TR 17223:2018 | Identical |
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