NEWS | New Notified Body designated for IVDR

February 19, 2025

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]

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NEWS | FAQs on the European Health Data Space

The EHDS Regulation has three main parts, each with different addressees:

Chapter II on primary use provides additional rights to patients and establishes the technical infrastructure necessary for their implementation.

Chapter III on Electronic Health Record (EHR) systems is addressed to manufacturers and other economic operators who make EHR systems available on the market.

Chapter IV on secondary use is addressed to health data holders and users.

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