Since the beginning of the European regulations on medical devices, Spain has opted to have a public notified body (ON) that declares the safety, quality and efficacy of medical devices entering the market as a single objective. This model eliminates threats that put at risk the independence and impartiality in the certification actions of these products, since both the continuity of the organization and the remuneration of all staff are totally independent of the volume and result of activity. The performance of the actions of ON 0318 is permeated by our strong commitment to public service and is based on the trust of our customers.
The new European regulations have changed the process of monitoring and controlling NOs, establishing very strict criteria that they must meet in order to be designated. To meet this challenge, it has been necessary to undertake profound internal changes in the quality management system, process management and staff qualification systems. The most outstanding change is represented by the new organizational structure of the AEMPS, a prerequisite for strengthening the guarantees of independence between the ON and the competent authority.
The creation of the National Center for Certification of Medical Devices (CNC) reinforces the commitment of the General Administration of the State to promote and support the industrial sector of these products in Spain, providing a framework for them to be placed on the market without adding linguistic, cultural or geographical barriers.
CNC has implemented a systematic approach to ensure that personnel involved in conformity assessment have the appropriate competence to make critical judgments independently and impartially. In this regard, I would like to point out that my absence of conflict of interest, as well as that of the Secretary-General, are documented and I make it known that neither of us have any interest in the health products industry, we do not provide any consultancy or advisory services, nor do we provide training to private companies in the sector.
The legislative change has given us the opportunity to think again about where we want to be and what we want to do. From ON 0318 we were clear: we wanted to continue certifying products with the Spain brand. Once achieved, the designations for the MDR and for the IVDR are ready to continue to carry out our work with professionalism, integrity and rigor, always bearing in mind our horizon: to promote progress and excellence in the health products sector.
As always, I would like to thank all our clients for their loyalty and the trust placed in choosing us as a notified body and certification body. For me it is a real honor to be at the forefront of CNC’s living the great challenge of getting the products Legacy legacy have the CE marking according to regulatory changes and that innovative products enter the market in an agile and prompt way so that they bring the expected benefit to patients when needed. We face this journey working responsibly and with great enthusiasm.
Gloria Hernandez, Head of CNC Engineering
February 2025