- The Spanish agency will be able to assess the conformity of these key products in healthcare to be marketed in the EU
- The designation consolidates the CNCps as a national benchmark in this strategic sector and increases the European capacity to absorb the great demand for certification and thus avoid the potential shortage of these products.
- The CNCps will be able to continue supporting the Spanish industry, represented mostly by small and medium-sized companies, with a great strength at European level in the health products sector
The National Center for Medical Device Certification (CNCps) will be able to certify medical devices from now on in vitro to be marketed in the European Union. The European Commission this morning published the designation of CNCps as Notified Body 0318 for the Regulation (EU) 2017/746 of 5 April on in vitro diagnostic medical devices (IVDR). In this way, the Spanish agency joins 13 other European entities that are authorized to evaluate the conformity of these products before the manufacturer puts them on the market. The designation consolidates the CNCps as a national reference in this strategic sector that includes key products in healthcare such as reagents for neonatal screening, self-diagnostic testing of infectious diseases or markers of oncological stratification.
The designation of CNCps increases Europe’s capacity to absorb the high demand for certification resulting from the new requirements required by the regulation, thus avoiding the potential shortage of these essential products for the diagnosis or help in the diagnosis of diseases, as well as for establishing or supervising therapeutic measures. It also highlights the capacity and technical competence of CNCps as a public body ensuring that manufacturers’ CE marking requests are met with the highest degree of integrity, transparency and professional rigour.
The appointment process, which has lasted more than two years, has been completed with the publication of the scope of CNCps, which includes 73 of the 80 codes into which the certification activity is divided. This broad spectrum allows us to continue supporting, from a public and accessible body, the Spanish industry represented mostly by small and medium-sized companies but with a great strength at European level in the health products sector. In addition, the Centre may continue to respond to requests from foreign manufacturers who, for any reason, choose the Spanish notified body as the supervisory body.
Manufacturers who wish to do so will be able to start making requests through the CNCps application from 1 March 2025. Detailed information on the conditions, costs and forms for doing it is available in the CNCps website. Similarly, the manufacturers of products legacy (those that were marketed before the date of application of the IVDR) that do not yet have the certification projects fully aligned with the IVDR, will be eligible to apply for a “conditional admission”. In this way, they will be able to continue marketing their products according to The conditions and deadlines for extension establishing Regulation (EU) 2024/1860.
In addition to the certification of new medical devices to which the products for diagnosis are now added in vitro, the CNCps maintains its activity regarding the certification of the UNE EN ISO 13485 standard, under ENAC accreditation and for the activities of supervision and control of CE marking certificates issued under Directive 93/42/EC of Medical Devices and Directive 98/79/EC of Medical Devices for Diagnosis In Vitro, whose manufacturers have benefited from the extension periods.