CQS, designated EU Reference Laboratory

Consulting Quimico Sanitario (CQS) celebrates its twentieth anniversary in the best possible way, as on 6 December 2023 it was designated as a European Union Reference Laboratory (EURL) in the field of in vitro type D medical devices. The publication of the European Commission’s Implementing Regulation (EU) 2023/2713 is a designation that follows the line of innovation and leadership that for CQS meant being the first private clinical laboratory in Spain to be accredited by ENAC.

The CQS team is very proud of this designation, of being the only private laboratory to have achieved this European milestone, and of being able to contribute to a European Health Union that, in the words of the European Commission, should enable all EU countries to prepare for and respond together to health crises, as well as to have innovative and reliable medical supplies.

What is the purpose of the European Reference Laboratories?

With the designation of the five EURLs,1 the European Commission aims to ensure that the placing on the EU market, marketing and putting into service of in vitro diagnostic medical devices for human use takes place with full health and quality assurance for EU citizens.

Designation

The designation of CQS as an EURL occurs in two categories of Class D medical devices: (i) products intended for the detection or quantification of herpesvirus markers; and (ii) products for the detection and quantification of markers of bacterial infections. Products for which CQS will be responsible include

  • Verification of the manufacturer’s declared performance and compliance with the common specifications.
    • The analysis of samples or batches. 
    • Scientific advice to selected European and national institutions. 
    • Recommendation on reference materials and measurement procedures.

Process

The appointment was the culmination of a long and extremely demanding process. CQS has had to accredit the knowledge and experience of its staff; the necessary equipment and reference materials; integration and compliance with international standards and best practices; economic viability outside the EURL network; and professional independence.

In this sense, the significant previous experience in Spanish and European R&D&I projects, the high capacity of our team and the advanced technical means at our disposal, as well as our comprehensive commitment to quality in healthcare environments (including our own software solutions such as the SmartQMS) have been our best letter of introduction.

1. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (ALE); Instituto de Salud Carlos III (ESP); Consorcio gestionado por el Servicio Madrileño de Salud (Hospital General Universitario Gregorio Marañón, Hospital Universitario la Paz and Hospital Universitario Ramón y Cajal) (ESP); Consulting Químico Sanitario SLU (ESP); and RISE Research Institutes of Sweden AB (SUE).