CEN/CLC/TC 3
| Project No. | CEN/TR 17223:2018 |
|---|---|
| Title | 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. |
| Registration number (WIID) | 64861 |
| Scope | 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. |
| Status | Atcelts |
| ICS group | 03.100.70 11.040.01 |