AseBio welcomes the designation of CNCps as a Notified Body for Certifying In Vitro Diagnostic Medical Devices

On Wednesday, February 19, the European Commission published the designation of the National Center for the Certification of Medical Devices (CNCps) as Notified Body (NB) 0318 for Regulation (EU) 2017/746 of April 5 on in vitro diagnostic medical devices (IVDR). After a process lasting over two years, this decision allows the Spanish body to join the other 13 European entities authorized to assess the compliance of these products before they enter the market. Manufacturers will be able to start submitting applications from March 1, 2025, through the platform enabled by CNCps.

At AseBio, we welcome this news and trust that the designation of CNCps as a Notified Body will help alleviate the bottleneck caused by the high demand for certification, which has particularly harmed innovative biotechnology companies developing IVDs.

The current lack of capacity and the increased regulatory requirements under the new legal framework have had a particularly severe impact on small companies, many of which depend on the commercialization of a single or a very limited number of products. In this context, with CNCps’s designation, we believe that priority should be given to innovative products developed by Spanish companies, particularly SMEs.

Given the challenges posed by the increased certification needs under the new legal framework, the necessary updates for products previously approved under the former framework, and the limited capacity of the European certification system, we believe that CNCps’s designation alone will not fully resolve the existing bottleneck. Therefore, at AseBio, we propose continuing to promote the designation of new Notified Bodies in our country, allowing private certification and verification entities in Spain to be designated as Notified Bodies, as is the case in most of the European Union (EU).

Additionally, to help Spanish companies comply with the regulation and navigate the certification process successfully, we consider it necessary to establish scientific and regulatory advisory mechanisms similar to the role played by the Office for Innovation Support and Knowledge on Medicines for research groups and start-ups in the pharmaceutical sector.

At AseBio, we extend our support to the Administration, and particularly to CNCps, to facilitate companies' compliance with the requirements introduced by Regulation (EU) 2017/746 through training initiatives. This will help prevent negative responses to their applications, which could otherwise delay innovation and ultimately harm citizens.