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With the designation of the five EURL¹, the European Commission aims to ensure that the placing on the EU market, placing on the EU market, placing on the market and putting into service of in vitro diagnostic medical devices for human use, is produced with full health and quality guarantees for EU citizens.
On 5 December 2023, the European Commission adopted an act designating five EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs). These laboratories will cover categories such as hepatitis, retroviruses, herpesviruses, bacterial agents and respiratory viruses causing serious diseases. EURLs will perform conformity assessments and advisory tasks, starting their functions on 1 October 2024.
The appointment has been made in accordance with the following call for applications: Commission Implementing Regulation (EU) 2023/2713 designating EU reference laboratories in the field of in vitro diagnostic medical devices.
The act includes provisions to minimise disruption to ongoing conformity assessment processes. In particular, only new applications submitted to notified bodies after the end of the transitional period will be subject to performance verification by EURLs. On the other hand, batch testing of products already CE marked under Regulation (EU) 2017/746 will commence after the end of the transitional period to ensure adequate control of these IVDs.
For more information, visit the official announcement.
Contact us to access CQS EURL-IVD services or receive more information:
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
In this sense, the important previous experience in Spanish and European R+D+i projects, the very 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 SmartQMS) have been our best letter of introduction. software solutions such as SmartQMS) have been our best letter of introduction.
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.
Implications
According to Article 100 of Regulation (EU) 2017/746, EURLs are required for several important tasks. These tasks include the verification of the performance of devices against the applicable common specifications, batch testing of class D devices and the provision of scientific and technical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States and Notified Bodies in relation to the implementation of this Regulation.
In addition, the tasks of the EURLs include the development of test and analytical methods for conformity assessment and market surveillance.
Importantly, EURLS will collaborate with Notified Bodies in the development of best practices for the conduct of conformity assessment procedures. In accordance with Article 100 of Regulation (EU) 2017/746, EURLs shall also contribute to the development of common specifications and international standards.
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 details the tasks and criteria for EURLs in the field of in vitro diagnostic medical devices, and in July 2022 the European Commission launched a call for EURL applications.
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).
References
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
- Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down detailed rules for the implementation of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices.