Consulting Quimico Sanitario (CQS) celebrates its 20th anniversary in the best possible way. On December 6th, 2023, CQS was designated as European Union reference laboratory (EURL) in the field of in vitro class D diagnostic medical devices. This designation was officialised in the Commission Implementing Regulation (EU) 2023/2713 and followed on the footsteps of the innovation and leadership showcased by CQS when, in 2008, became first Spanish private laboratory internationally certified with the ISO 15189 standard.

CQS is very proud of this accomplishment, which also means being the only private laboratory that has reached this European landmark, and contributing to the EU4Health programme that, in the words of the Commission, aims at allowing all EU member states to better prepare and respond to health threats, as well as easing the access to innovative and reliable medical devices.

What is the objective of the European Union reference laboratories

By designating five EURLs,1 the European Commission intends to assure that medical devices introduced, commercialized, and commissioned in the EU Single Market comply with all sanitary and quality guarantees.

Designation

CQS has been designated as EURL for medical devices intended for detection or quantification of markers of (i) herpesvirus infection, and (ii) bacterial agents. Among others, CQS responsibilities will extend to:

  • verify the performance claimed by the manufacturer and the compliance with the applicable common specifications.
  • carry out tests on samples or batches.
  • provide scientific and technical assistance to certain European and national institutions.
  • provide recommendations on reference materials and measurement procedures.

Process

The designation process was exhaustive. CQS has proven the knowledge and experience of its staff, its equipment and reference materials; the integration of international standards and best practices; the viability without financial assistance from the EU and its professional independence.

In this regard, CQS previous experience in European and Spanish RDI projects, the expertise of the team and the advanced technical means, as well as CQS major bid in quality in health environments (even developing a software solution SmartQMS) have been the best presentation.

1. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (GER); Instituto de Salud Carlos III (SPA); Consortium managed by Servicio Madrileño de Salud (Hospital General Universitario Gregorio Marañón, Hospital Universitario la Paz y Hospital Universitario Ramón y Cajal) (SPA); Consulting Químico Sanitario SLU (SPA); and RISE Research Institutes of Sweden AB (SWE).

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