S.R. 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
01-01-2018
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National Foreword
European Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Relationship between the European Regulations
for Medical Devices and in vitro Diagnostic
Medical Devices and the clauses of EN ISO 13485
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
|
| Pages |
90
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| CEN/TR 17223:2018 | Identical |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
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