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- The company has been one of the five entities in Europe, three of them Spanish, designated by the European Commission for the certification of Class D in vitro medical devices.
- CQS collaborates with the industry and participates in the Symposium of the Spanish Association of Industry Pharmacists (AEFI) in the context of the new European regulation.
In 2024, the European Union starts to implement the regulation of in vitro medical devices and, for the first time, will have reference laboratories that will have to certify all these products, starting with the so-called “class D” products, so that they can obtain the CE marking. By the end of 2023, a total of five EU laboratories have been designated to carry out this work, which will begin in the coming months, including three Spanish laboratories. Consulting Químico Sanitario (CQS) has been the only private laboratory to obtain this qualification and is preparing for the task ahead. “Those of us at CQS are very proud to have received the designation as a European Reference Laboratory (EURL) and we are preparing ourselves responsibly to meet the challenge. This was stated by Dr Juan José Álvarez Millán, CEO of CQS, during his speech at the 42nd Symposium of the Spanish Association of Industry Pharmacists (AEFI), held in Madrid.
Precisely the new European regulation and the challenges it poses for the industry and for reference laboratories were the focus of the round table “Class D IVD products? Reference laboratories respond”, in which Álvarez Millán participated together with Ana Avellón, EURL coordinator at the Carlos III Health Institute, and Laura Figuero, technician at the Spanish Agency for Medicines and Health Products (AEMPS). The CEO of CQS recalled that, last December, the EU Implementing Regulation 2023/28713 decided for the first time on this type of assessment bodies, the European reference laboratories. Of the five selected, one is in Germany, one in Sweden and three in Spain, “which gives an idea of the level of excellence of the research centres and professionals in our country”, he stressed.
Two of the laboratories in Spain are public (the ISCIII and a consortium formed by the La Paz, Ramón y Cajal and Gregorio Marañón University Hospitals in Madrid). The third, and only private, is CQS. A designation which, in the words of Álvarez Millán, “represents the latest milestone in a process marked by quality that we undertook two decades ago”. In his speech, he recalled that this path began with “a small company, a traditional clinical analysis laboratory” and in 2008 CQS was the first private clinical laboratory in Spain to be accredited by the National Accreditation Entity (ENAC). In 2017 it undertook its first European project, and this was the origin of the designation as EURL. A “long and extremely demanding” process in which “CQS has had to prove the knowledge and experience of its staff, the equipment and reference materials, the integration and adaptation to international standards and best practices and its economic viability, as well as its professional independence,” explained its CEO.
New regulation since October
The round table on IVD Products discussed the new European regulation, which will be implemented on 1 October 2024. This regulation stipulates that in vitro diagnostic products must be certified by a EURL to obtain the CE marking, in order to reinforce safety and efficiency.
An in vitro diagnostic medical device is any reagent, calibrator, control material, kit, instrument, apparatus, device, equipment or system, used alone or in association with others, intended by the manufacturer to be used in vitro for the study of specimens originating from the human body, including blood and tissue donations. In turn, these products are divided according to risk into class A, B, C, and D, with class D products presenting the highest risk. The new regulation will start to apply to the latter, Class D IVDs. In the case of CQS, the EURL designation is for the evaluation of two subcategories of Class D IVDs: products intended for the detection or quantification of herpes virus markers, and products intended for the detection and quantification of markers for bacterial infections.
Until now, 90% of the products were traded unverified, only on presentation of the relevant documentation. Through the designation of the five EURLs, the European Commission aims to ensure that the placing on the EU market, marketing and putting into service of these high-risk class D in vitro diagnostic medical devices for human use takes place with full health and quality guarantees for the citizens of the European Union.
The new system, explained Álvarez Millán, “will serve to provide greater security and transparency, but also more legal clarity for companies”. The CQS CEO said he understood “the industry’s interest and desire to know”, for which he thanked AEFI for the opportunity to present itself as a EURL to the sector. In his view, the new regulation will also bring another advantage to companies, as the manufacturer will not have to assess its devices in isolation in each country, but only once for the whole EU.
He also expressed confidence that having reference laboratories will be a further step in favour of the health of Europeans. “We hope that this milestone will contribute to progress towards a European Health Union that will enable, as the European Commission has pointed out, all member countries to be prepared to respond jointly to health crises and to have innovative and reliable medical devices at their disposal. We are preparing to be part of this process,” he concluded.