Today marks the announcement of CNCPS (Centro Nacional de Certificación de Productos Sanitarios), the Spanish Notified Body, as an official Notified Body for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
With the designation of CNCPS, there are now 13 Notified Bodies authorised to issue CE certificates for in vitro diagnostic medical devices in accordance with the IVDR.
For more details on the designation, including product typology codes and conformity assessment processes, please see the link: EUROPEAN COMISSION NOTIFICATION DETAILS
Congratulations to the MedTech industry and CNCPS!
Need help in Regulatory Affairs for Medical Devices? Contact us: [email protected]