With the In Vitro Diagnostic Medical Devices Regulation (IVDR), the IVD sector in the European Union is about to experience significant changes. From a new classification system to stricter assessment procedures and market surveillance, the 26th May deadline represents a landmark for all stakeholders.
One of the fundamental changes brought by the IVDR is the establishment of EU Reference Laboratories (EURLs). EU Reference Laboratories are scientific laboratories within the European Union designed to ensure safety and compliance of IVDs with the Regulation. While discussions on practical aspects of such laboratories are ongoing and their requirements have been drafted, the structures selected as EURLs should be defined only at the beginning of 2023.
Requirements for becoming a reference laboratory
During the first quarter of 2022, the European Commission should publish an official call for applications addressed to laboratories all over the European Union. Laboratories must fulfil specific criteria in order to apply and potentially be designated as EURL. In the latest drafted implementing act on criteria and tasks of the EURLs, specific requirements have been presented for public consultation. Some of the main requirements are listed here:
– Experienced and sufficient number of staff with technical, scientific and administrative background
– Adequate equipment and reference materials necessary to carry out the tasks and related processes well documented
– Knowledge and implementation of international standards and best practices
– Confidentiality policy covering data and information gained through testing
– Independence and safeguard of public interest (confirmed by the Member State)
– A policy to identify and prevent conflict of interest
Laboratories fulfilling these and all other requirements listed here are invited to apply upon application call.
Tasks performed by reference laboratories
For some devices or groups of devices, generally related to specific hazards or higher risks, the notified body and the Member State can request further verifications from EURLs. As designed by the IVDR and further specified in the draft implementing act, the EU reference laboratories would have the following tasks:
– Verification of the performance claimed by the manufacturer and the compliance with the Common Specifications or other solutions
– Performance of tests on samples of manufactured class D devices or batches of class D devices
– Providing scientific and technical assistance, opinions, and advice
– Set up and management of a network and sub-networks of reference laboratories
– Contribution to the development of appropriate testing and analysis methods
– Collaboration with notified bodies in the development of best practices
– Providing recommendations on suitable reference materials and measurement procedures
– contribute to the development of Common Specifications (CS) and international standards
EURLs are mostly foreseen for class D devices. Nonetheless, the Commission may also assign an EU reference laboratory for class C devices when a Member State requests it.
The idea is to create a broad network of laboratories all over the European Union that will make the market for IVDs safer and strictly compliant. Such laboratories will also have to adopt harmonised methods. This means that they should, among other things, apply coordinated methods, procedures, and processes, use the same reference materials, common testing protocols, and standardised test reports. Moreover, the network of laboratories is invited to cooperate in organizing regular quality assessment tests, agreeing on joint guidelines, and coordinating the introduction of testing methods for new technologies.
Financial contribution for EURLs
EURLs could receive financial contributions from the European Union. A recently published/released draft implementing act presented possible terms for EURLs to stipulate their fees. Generally, reference laboratories can charge fees to cover all or part of the costs to perform their tasks. The method used for the calculation of such fees should be based on the costs generated by the requested tasks. The calculation of the fees should be transparent and based on estimations as close as possible to the final actual costs. The charged fees can include costs for staff, equipment, shipping, consumables, test specimens, reference materials, translations, and other general costs.
Possible implementing acts to the IVD Regulation, specifically concerning the EU Reference Laboratories, will be published in the Official Journal of the European Union and on MDlaw.
Are you an IVD manufacturer and wishing to place your device on the EU market?
Obelis will gladly assist you in the compliance process of your IVD!
Simona Varrella
Expert Consultant, Publications Department
18.02.2022
References:
European Commission. (2021). Draft implementing regulation laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices. Retrieved on 18/02/2022 from https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13273-EU-reference-laboratories-EURL-detailed-rules-on-tasks-and-criteria_en
European Commission. (2021). Draft implementing regulation laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices.Retrieved on 18/02/2022 from https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EU-reference-laboratories-EURL-detailed-rules-on-the-level-and-structure-of-fees_en
Official Journal of the European Union. (2021). Regulation (EU) of the European Parliament and of the Council of 5April 217 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and