El National Center for Health Product Certification (CNCps) publishes theMemory of Activitiescorresponding to the year 2023, in which it reviews the first year since its establishment and its designation as a notified body under Regulation (EU) 2017/745 of 5 April regulating medical devices (MDRs). The broad scope of the MDR designation finally achieved (29 of the 44 purpose codes, MDA and MDN, and 25 of the 27 horizontal codes, MDT and MDS), has allowed most companies that had their products certified with ON 0318, to also apply for the CE marking in accordance with the MDR. Therefore, during the year 2023, the main activity of ON 0318 has been focused on the processing of initial applications for CE marking under the MDR. Since 12 September 2022, the date of receipt of the first application for certification under the MDR, Notified Body 0318 has been receiving and formalising applications from well-known companies, but also from 24 other new companies applying for the CE marking for the first time.
As of December 31, 2023, there were 38 companies with signed agreement for the certification of MDR and 34 companies in initial CE MDR processing representing a total of 165 applications, since each company makes as many applications as products or groups of products it has. During the year 2023, the ON 0318 has issued 11 EU certificates according to the MDR that cover 26 products: 10 are of quality management system and 1 of technical documentation evaluation.
The time of issuance of the certificates since the acceptance to process the application has varied in range from 4 to 15 months.
The year 2023 has been a year of premiere of the MDR designation for the ON 0318 and, therefore, a year of continuous learning. It has also been a year in which constant communication with manufacturing companies has been necessary to expose the expectations of ON 0318, establishing those “structured dialogues” to which the European Commission and the MDCG urged the notified bodies. In this first year, the ON 0318 has witnessed the great effort that Spanish companies in the sector have made and are making to obtain objective evidence of the conformity of the products calledlegacy(those that were marketed before the date of application of the MDR) with the new or revised requirements that appear in the MDR, as well as the implementation of new document control systems to have technical files with the structure and content standardized in MDR providing complete, clear, organized, easy to search and unambiguous documentation.
Designation for the IVDR
The designation process for Regulation (EU) 2017/746 of 5 April on medical devices for diagnosisin vitro(IVDR), started in July 2021, has continued its course, highlighting in 2023 the four deliveries of complementary documentation related to the corrective action plan undertaken by CNCps to solve the nonconformities of the audit carried outin situby the European Commission's joint assessment team (Joint Assessessment Team), in October 2022.
The CNCps team, aware of the impact that the designation according to the IVDR entails in the strategic plans of companies and, therefore, in the maintenance and development of the industrial tissue of medical devices for diagnosisin vitroin Spain, it is working quickly to speed up the appointment process as much as possible and is soon in a position to accept applications for conformity assessment of medical devices for diagnosisin vitroaccording to the IVDR.