Conformity assessment
If an IVD bears the CE marking demonstrating conformity with the IVDR, it may be placed on the market or put into service. To assess conformity, the device must fulfill the GSPRs (see IVDR Annex I). Additionally, it and must have a technical documentation according to Annex II and III of the IVDR. Further, the conformity assessment procedure of the IVDR is based on the risk classification (see IVDR Annex VIII).
An overview of the conformity assessment routes per IVDR risk class is provided in the picture below:
The IVDR permits only for class A (non-sterile) products a manufacturer’s (self-)declaration of conformity (see IVDR Article 48 (10)). A complete quality management system, must be implemented and applied for device classes A (sterile devices), B, C and D. It will be assessed by a notified body. In addition, the technical documentation must be checked for classes B, C and D by a notified body. An additional sample/batch inspection and a safety/performance verification by a reference laboratory is required for class D devices (see IVDR Article 100).
