The National Center for Health Product Certification (CNCps) publishes the Annual Report 2022, a year marked by the creation of the CNCps and its designation as a notified body under Regulation (EU) 2017/745 (MDR). This designation entitles CNCps to certify MDR-protected medical devices that fall within the scope of the designation. The CNCps thus inherits the experience, knowledge and rigor of the AEMPS Certification Area, which has been performing these functions since 1995. Annual Report 2022 details how CNCps is also working to be designated under Regulation (EU) 2017/746 (IVDR).
During the year 2022, CNCps has seen a 120% increase in the number of new customers (from 9 new additions in 2021 to 20 in 2022), with a total of 119 customers. The data presented in the Annual Report 2022 show that during the past year the growing trend in the volume of CNCps activity continued. This increase, on the one hand, reflects the dynamism and strength of industrial activity in the health products sector in Spain and, on the other, the confidence that customers continue to place in the CNCps in its performance as ON 0318 and as a certification entity of the UNE EN ISO 13485 standard.
In 2022, the CNCps has complied with the planned audit plan, carrying out 124 audits that have required 467 auditor actions/day (total audit days for the number of people who have attended). Since September 15, 2022, it has received 43 applications for product certification according to the MDR. 30% of these applications correspond to new companies and it should be noted that 37% of them correspond to implantable products and 10% to medical products software. As of December 31, 2022, 19 companies were in the process of CE certification according to the MDR.
The Notified Body 0318, responsible for certifying medical devices for diagnosis in vitro in Spain, it certified a total of 15 products in 2022 according to the already repealed Directive 98/79/EC before the deadline for its emission on 26 May 2022. This body, attached to the Spanish Agency of Medicines and Health Products (AEMPS), maintains the certificate of 1,159 health products, of which 18% are of maximum risk, such as vascular and traumatological implants or spinal needles, and another 11% are considered reagents with high impact on public health, such as those used for blood screening in transfusion centers.
On the other hand, regarding the activity of the CNCps regarding the issuance of certificates under the ENAC accreditation for the UNE EN ISO 13485 standard, as of December 31, 2022 there were 71 companies with this certificate in force, of which 61 were Spanish and 10 from Italy, France, Portugal, Canada, Argentina and Mexico. With regard to 2020, the percentage of certificates issued to third-party service providers has gone from 6.6% to 22.5%, a fact that evidences that all economic agents related to the health products sector are aware of the need to have implemented a good management and quality system, which ensures that adequate records are maintained that demonstrate the traceability, upstream and downstream, of health products that access the market.
The ON 0318 maintains an outstanding international activity, facilitating the access of sanitary products manufactured in Spain to the European market and other international markets: around 10% of the companies certified by the CNCps are foreign companies. In 2022, certificates were issued to companies located in France, Italy, Portugal, United States, Canada, Argentina, Mexico and Jordan. In addition, it also audited companies located in Italy, Puerto Rico, China and Japan that are subcontracted by ON 0318 customers.