It has been more than a year since Regulation 2017/745 (commonly known as MDR “Medical Devices Regulation”) came into force and since then we are facing a serious problem due to the significant reduction in the number of Notified Bodies. The tightening of the requirements and the shortage of certifying bodies means that we are facing a bottleneck.
Last week the AEMPS notified the designation of the national Notified Body, finalising a process that started in July 2019 but was postponed due to the pandemic and resumed in 2021. Likewise, work is underway on the designation as a body for Regulation (EU) 2017/746.
Now the Centro Nacional de Certificación de Productos Sanitarios (CNCps) has been accredited as the first Notified Body in Spain. It has been designated by the Ministry of Health for the conformity assessment of medical devices. It is also accredited by the Spanish National Accreditation Body (ENAC) for the certification of quality management systems in accordance with the UNE EN ISO 13485 standard “Medical devices. Quality management systems. Requirements for regulatory purposes”.
Information on the scope and fees can be found on the aemps website in the “ON 0318/Norma 13485” section:
www.aemps.gob.es
Or on the website created for the body:
certificaps.gob.es
Submissions will be made through the application launched last year:
The official website of the Notified Body:
