Medical devices, European database under the lens of clinical engineers

Clinical engineers are following “carefully” the application of the new European Regulation on medical devices (MDR 2017/745), which has set “high standards of quality and safety” for these products and created Eudamed, the European database of medical devices, considered “central tool for the integration and verification of different products and systems”. The topic was discussed in Milan during the 21st National Conference of the AIIC, the Italian Association of Clinical Engineers, to “grasp the first points of relapse of the Regulation” created with the aim of guaranteeing “the proper functioning of the internal market as far as it concerns medical devices – the AIIC recalls in a note – taking as a basis a high level of protection of the health of patients and users and taking into account the small and medium-sized enterprises active in this sector “. “Unfortunately, today many pieces of the standard are still being defined – says Stefano Bergamasco, coordinator of the Aicc Study Center and moderator of the conference sessions on the new Regulation – The most important aspect in our opinion is precisely that the new Eudamed database, which will become the official European repository of the medical devices sector, has activated only the first application modules and its use by the system actors is still on a voluntary basis. This means that the registration process of all medical devices, as expected, given its complexity, it is not absolutely immediate. On the contrary: we have now understood that it will take a few years for Eudamed to be fully operational and mandatory. This introduces a vulnerability in the overall architecture of the Regulation and of the verification system, as the database is the fundamental element of the entire registration, compliance, supervision and surveillance system ” And in the meantime? After the Regulation has entered into force, how is the system of producers, professionals and national control agencies behaving? “I believe that we are all well aware of the delicacy of this period of transition – comments Bergamasco – As clinical engineers we are carrying out, also through our association, training activities with various proposals, not only within our conference, to develop professional culture on the most critical and impact of MDR 745/2017 on clinical engineering. We are also producing updates in collaboration with the most relevant stakeholders such as the European Commission, which was present in our conference sessions, the Ministry of Health and trade associations. we are faced with significant, stimulating and delicate innovations, but we are ready as clinical engineers to dialogue with the other stakeholders on the many aspects present in the Regulation still being defined “.