The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD sector. In line with stricter assessment procedures, the Regulation introduced the EU Reference Laboratories (EURLs). The EURLs will have advisory tasks, in particular related to conformity assessment, especially of the highest risk, i.e., class D devices. For the conformity assessment of class D devices, the EURLs will:
- verify the performance of class D devices and compliance with common specifications
- perform batch testing of class D devices
Recently, there was an EU consultation open for feedback on practical aspects and requirements of the Laboratories. In June 2022, the European Commission published measures through two Implementing Acts to define their criteria, tasks, and fees.
Criteria of EU Reference Laboratories
As laid down in Implementing Regulation (EU) 2022/944, the criteria for the EU Reference Laboratories include:
- Staff. The EURLs have to document and justify the knowledge and experience requirements of the staff. Especially, the director, the scientific, and the technical staff have to have the experience to fulfill tasks in the field of specific devices and hazards related to them. Additionally, the number of people employed has to be proportional to the tasks to perform, while the personnel constantly trained.
- Equipment and reference materials. The EURLs have to keep up-to-date documentation containing an explanation of the equipment and reference materials used, evidence of the availability of such equipment and reference materials, and a plan for the procurement of the materials used (specimen, control materials, reference materials).
- International standards and best practices. The EURLs have to keep up-to-date documentation containing a list of international standards and best practices as well as evidence that they have integrated such standards to their procedures.
- Administrative organisation and structure. The EURLs must have one person within its management who is responsible for the performance of the EURLs’ tasks. Additionally, there has to be enough administrative staff for the amount of administrative support required. The Laboratories have to keep administrative data in up-to-date documentation. Among others, such documentation includes the role of the employees in external organisations, evidence of financial availability without the assistance of the EU, and an annual overview of the tasks performed.
- Confidentiality. The Laboratories must have a confidentiality policy which includes: the type of information to consider confidential, rules for handling, storage, and sharing of information as well as rules for granting access to and sharing confidential information to a competent authority.
- Public interest, independence and conflicts of interest. EURLs have to perform tasks in the public interest and in an independent manner. Therefore, the staff cannot have any type of interest in the IVD industry which could affect their impartiality. In this sense, the policy of the Laboratories needs to include steps to prevent, identify, and resolve conflicts of interest.
- Outsourcing of testing and access to equipment from other laboratories. The EURLs can assign testing or part of testing to national reference laboratories when the volume of testing requires so. Similarly, the EURL can enter in contact with an external laboratory or another EURL to access additional equipment or materials necessary for the testing. However, the EU reference laboratory has the responsibility for the final results.
- Accreditation. The accreditation of the EU reference laboratories occurs in accordance with the harmonised standard EN ISO/IEC 17025.
- Verification of compliance with criteria. The Member States have to verify that the laboratory which applies as a EURL is compliant with the requirements laid down by the IVDR.
Tasks of the EU Reference Laboratories
As laid down in Implementing Regulation (EU) 2022/944, the tasks for the EU Reference Laboratories include:
- Contracts between the EU reference laboratories and requesting parties. The EURL needs to enter into an agreement with the involved parties when performing a task. The parties involved are the notified bodies and the Member States. Such agreement has to define terms, conditions, and time schedule of the task.
- Requests from notified bodies. When a notified body stipulates a contract with a EURL, the notified body has to submit all required documentation, information, equipment, and reference materials related to the device. Moreover, the notified body has to train the staff of the EURL on the use of the equipment provided.
- Verification of performance and compliance with common specifications. The EURL has to verify that the device under their inspection complies with common specifications or with other solutions chosen by the manufacturer. In order to verify the performance of the device, the Laboratory can decide what tests are necessary. More specifically, timelines and deadlines to provide their opinions are set in Article 12 of Implementing Regulation (EU) 2022/944.
- Sample or batch testing. The notified body has to propose a sample or batch test plan for the device to the EU reference laboratory. Furthermore, the notified body shall provide the EURL with the opinion as well as with any previous findings issued by another EURL. Lastly, the notified body is responsible for logistic arrangements with the EU reference laboratory to ensure that the Laboratory has enough time after the reception of the samples to perform the tests.
- Requests to perform tasks. The European Commission can request to carry out tasks to a EURL, either on its own initiative or upon request from the Medical Device Coordination Group (MDCG). Similarly, also notified bodies can request to carry out tasks to a EURL.
- Setting up of a network of national reference laboratories. Competent Authorities need to inform EU Reference Laboratories of any laboratory designated as EURL. The EURLs or the sub-network (such as national reference laboratories) have to share relevant information and promote the use of common testing methods within the network.
- Recommendations on suitable reference materials and reference measurement procedures of higher metrological order. The Laboratories have to review, publish, and update recommendations on the available reference materials and reference measurement procedures of higher metrological order.
- Sub-networks of EU reference laboratories. When more than one EURL has been assigned to a device, the Laboratories involved need to form a sub-network. In particular, the sub-networks develop, report, and ensure follow-up about the proficiency of the tests performed.
- Common rules of procedure. The EU reference laboratories shall adopt common rules of procedure for all EU reference laboratories when proposed and agreed by the Commission. The EURLs have to make such common rules available on their websites, reviewed them, and update them when necessary.
Fees of the European Reference Laboratories
As laid down in Implementing Regulation (EU) 2022/945, the fees for the EU Reference Laboratories follow these criteria:
- Structure of fees. The fees of the EURLs cover: staff, equipment, consumables, and translation costs, costs for test specimens and reference materials, shipping costs for samples, and general operational costs.
- Level of fees. The fees have to be non-discriminatory, fair, reasonable, and proportionate. Specifically, the Laboratories calculate the fees based on incurred costs.
- Rules for the calculation of fees. The EU reference laboratories determine and publish on their websites the rules to calculate such fees.
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