IVDR Compliance: Progress in EU Reference Laboratories and consequences for High-Risk IVDs

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EU Commission evaluates EURLs

The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to ensure compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR). These designated laboratories play a vital role in upholding the safety and efficacy of high-risk in vitro diagnostic medical devices (IVDs) within the European Union (EU).

In accordance with Article 100 of Regulation (EU) 2017/746, the Commission has been diligently assessing the applications received for EURL designation. The EURLs are entrusted with key responsibilities related to IVDR compliance, including advisory roles and activities associated with market access, specifically for class D devices that carry the highest level of risk. These laboratories are responsible for verifying the performance and ensuring the conformity of class D devices with common specifications, as well as conducting batch testing.

While no EURLs have been designated under Regulation (EU) 2017/746 thus far, the European Commission launched a call for applications in July 2022, targeting eight categories of class D devices. These categories encompass various areas such as hepatitis and retroviruses, herpesviruses, bacterial agents, arboviruses, respiratory viruses causing life-threatening diseases, haemorrhagic fever and other biosafety level 4 viruses, parasites, and blood grouping.

Candidate laboratories were invited to submit their applications to the national contact points in their respective Member States by January 2023. Subsequently, Member States were responsible for submitting the applications on behalf of the candidate laboratories to the European Commission, with a deadline of March 31, 2023.

8 Laboratories apply for designation

As of the deadline, the European Commission has received eight applications for review. These applications are currently undergoing a comprehensive assessment based on the specific criteria outlined in the call for applications. The evaluation process ensures that applicant laboratories meet the necessary standards and possess the combined capacity to handle the expected volume of requests related to market access tasks.

The European Commission aims to conclude its assessment process by the third quarter of 2023. However, it has been determined that none of the applicant laboratories in the category of haemorrhagic fever and other biosafety level 4 viruses possess the required combined capacity to adequately address the anticipated volume of requests. Consequently, no EU reference laboratory will be designated for this particular category following the current call for applications.

Despite the absence of a designated EURL, manufacturers can still pursue conformity assessment of their IVDs through notified bodies, allowing for certification and lawful placement of products on the EU market in adherence to Regulation (EU) 2017/746.

It is important to note that additional calls for EURLs in the field of IVDs may be issued in the future, and relevant information will be published in advance to facilitate preparedness among stakeholders.

For detailed guidance on the integration of EURLs into the conformity assessment process once they are designated, manufacturers are encouraged to refer to MDCG 2021-4.

The establishment of EU reference laboratories marks a significant stride towards enhancing IVDR compliance and ensuring the quality and safety of high-risk IVDs across the European Union. The European Commission’s thorough evaluation process and steadfast commitment to regulatory compliance are instrumental in safeguarding public health and fostering innovation in the field of in vitro diagnostics.

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Q: What tasks do EU Reference Laboratories (EURLs) perform?

A: EURLs have a range of important tasks designed to ensure effective IVDR compliance. These tasks include:

  1. Verification of performance: EURLs verify the performance claimed by manufacturers and ensure compliance with Common Specifications or other solutions.
  2. Testing of devices: EURLs perform tests on samples of manufactured class D devices or batches of class D devices to ensure their quality and safety.
  3. Scientific and technical assistance: EURLs provide valuable scientific and technical assistance, opinions, and advice to support regulatory decision-making.
  4. Network management: EURLs establish and manage networks and sub-networks of reference laboratories to facilitate collaboration and exchange of knowledge and expertise.
  5. Development of testing methods: EURLs contribute to the development of appropriate testing and analysis methods for IVDs, promoting standardized practices.
  6. Collaboration with notified bodies: EURLs collaborate with notified bodies to develop best practices and ensure consistency in conformity assessment procedures.
  7. Recommendations on reference materials: EURLs provide recommendations on suitable reference materials and measurement procedures to enhance accuracy and reliability.
  8. Contribution to standards development: EURLs actively participate in the development of Common Specifications (CS) and international standards to align regulatory requirements.

Q: Are EURLs only for class D devices?

A: While EURLs are primarily intended for class D devices, there is provision for an EU reference laboratory to be assigned for class C devices upon request from a Member State.

Q: What is the purpose of creating a network of laboratories across the European Union?

A: The aim is to establish a broad network of laboratories throughout the European Union to enhance the safety and compliance of the IVD market. These laboratories will adopt harmonized methods, ensuring coordinated processes, consistent testing protocols, and standardized reporting. They will also cooperate in quality assessment tests, develop joint guidelines, and coordinate the introduction of testing methods for emerging technologies.

Q: How will EURLs contribute to making the IVD market safer and compliant?

A: EURLs play a crucial role in verifying device performance, conducting rigorous testing, and providing scientific expertise. By adopting harmonized methods and collaborating within the network, EURLs ensure consistency, accuracy, and reliability in the assessment of IVDs. This ultimately contributes to a safer and more strictly IVDR compliance framework within the European Union.

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