European Union Reference Laboratories (EURLs) for in vitro diagnostic medical devices (IVDs) under the in vitro diagnostic medical devices Regulation (IVDR 2017/746)

The HPRA, as the national competent authority for in vitro diagnostic medical devices (IVDs) in Ireland, is actively seeking expressions of interest from laboratories to be designated as European Union (EU) reference laboratories (EURLs).

Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) represents a significant strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directive, which has been in place for over 20 years. The IVDR introduces many changes including a rules-based classification system for IVDs. IVDs will now be classified into four different classes based on risk from class A (low) to class D (high). This will mean that regulation and assessment for each class of device will be proportional to the risk, and take into account the purpose intended by the manufacturer and inherent risks. The Classification Rules for IVDs are set out in Annex VIII of the IVDR. For further details and classification guidance please see the Guidance MDCG 2020-16 Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

As detailed in the IVDR, EURLs have a key role to play in verifying the safety and performance of IVDs both in the pre-market and post-market lifecycle of a device. Laboratories meeting the criteria for designation as an EURL are encouraged to apply for designation in order to contribute to a robust regulatory framework that has strengthened the European system of regulation and affords greater protection of public health.

Timelines/Expressions of Interest

The IVDR entered into force in May 2017 following publication in the Official Journal of the European Union. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period. However, the Regulation has a staggered transitional period with some aspects, such as the designation of EURLs, becoming legally binding before the five-year transition period ends. Article 100 (which shall apply from 25 November 2020) of the IVDR specifically outlines the relevant information for EURLs.

The HPRA anticipates that the European Commission will commence the process for designation of EURLs in early 2021. The designation will be based on submissions from the Member States or the Commission’s Joint Research Centre.

We are aware that further details would be beneficial around the specific requirements for laboratories who are interested in becoming an EURL. The European Commission are currently finalising Implementing Regulations that will provide detailed information regarding the tasks and criteria of EURLs along with the fees which may be levied. Once available, the HPRA will proactively communicate and publish the Implementing Regulations on this webpage. The HPRA are happy to assist with any queries in the interim. Please send any queries to devices@hpra.ie.

The HPRA at this time would welcome expressions of interest (via email to devices@hpra.ie) from laboratories meeting the specified criteria (outlined below). The HPRA requests that interested laboratories outline their particular areas of competence in relation to IVDs, when contacting the HPRA. The HPRA will continue to accept expressions of interest following the publication of the Implementing Regulations.

Criteria for Designation

Laboratories must satisfy specific criteria in order to be designated as an EURL. These criteria are specified in Article 100(4) of the IVDR such that a reference laboratory shall:

  • have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated;

  • possess the necessary equipment and reference material to carry out the tasks assigned to them;

  • have the necessary knowledge of international standards and best practices;

  • have an appropriate administrative organisation and structure;

  • ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks;

  • act in the public interest and in an independent manner;

  • ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs.

Tasks of EU Reference Laboratories

The tasks of the IVD EURLs are outlined in Article 100 paragraph 2 (Class D) and Article 100 paragraph 3 (Class C) of the IVDR, and are as follows:

Class D:

  • to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);

  • to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI;

  • to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation;

  • to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices;

  • to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks;

  • to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance;

  • to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures;

  • to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order;

  • to contribute to the development of CS and of international standards;

  • to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality.

Class C:

  • At the request of a Member State, the Commission may also designate the EU reference laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. 

Financing

EURLs may be granted a Union financial contribution. The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a Union financial contribution to the EURLs, taking into account the objectives of health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EURL, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions.

The Commission shall specify by means of an implementing act the structure and the level of the fees which may be levied by an EURL for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness.

Oversight of EU Reference Laboratories

EURLs shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If those controls find that an EURL is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation.