National call for Reference Laboratories for IVDs

Call for in vitro diagnostic Medical Device Reference Laboratories in accordance with the new in vitro diagnostic medical devices Regulation 

The HPRA, as the national competent authority for in vitro diagnostic medical devices in Ireland, is actively seeking expressions of interest from national laboratories to be designated as European Union (EU) reference laboratories for performance and compliance testing of Class C and Class D in vitro diagnostic medical devices (IVDs).  In accordance with the new proposals for a Regulation on in vitro diagnostic medical devices (IVDR), IVDs are divided into classes A, B, C and D, taking into account the purpose intended by the manufacturer and inherent risks.  The Classification Rules for IVDs as set out in Annex VII of the IVDR are included in the Appendix to this document and some examples are included for reference purposes.

EU Reference Laboratories have a key role to play in demonstrating 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 EU Reference Laboratory are encouraged to apply for designation in order to contribute at a national level to a robust regulatory framework that has strengthened the European system of regulation of medical devices and IVDs and affords greater protection of public health.  

Timelines

The proposal for a Regulation on in vitro diagnostic medical devices ( IVDR) has reached political agreement and is expected to be adopted in Q1 2017.   A transition period for full implementation is set out within the Regulation with the date of application for IVDs set at 5 years after entry into force.  There are a number of elements of the regulation that have a shorter transition time such as the designation of EU reference laboratories which will apply from 6 months prior to the date of application of the Regulation (i.e. from 4.5 years after entry into force).  This designation is provided for in Article 78  of the IVDR.

Expressions of Interest

The HPRA would welcome expressions of interest from national laboratories meeting the specified criteria outlined in Article 78 of the IVDR to be designated as an EU reference laboratory by 31st January 2017. These expressions of interest will be communicated on an informal basis to the European Commission and the IVD technical group (the European Commission’s expert working group on IVDs).

For further information on the designation process, interested parties should contact the HPRA directly by email: devices@hpra.ie, outlining their areas of competence in a particular IVD field.

Criteria for Designation

Laboratories must satisfy specific criteria in order to be designated as an EU reference laboratory.  These criteria are specified in Article 78 paragraph 3 of the proposed IVD Regulation 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 the 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 occur

 

Tasks of EU Reference Laboratories

The tasks of the EU IVD reference laboratories are outlined in Article 78 paragraph 2 (Class D) and paragraph 2a (Class C) of the IVDR and are as follows:

Class D:

  • to verify the claimed performance and the compliance of class D devices with the applicable Common Specification, 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 second subparagraph of Article 40(2);
  • to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 5.7 of Annex VIII and in Section 5.1 of Annex X;
  • to provide scientific and technical assistance to the Commission, the Medical Device Coordination Group (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 common specifications 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 after consideration of national provisions on confidentiality.
Class C:

At the request of a Member State, the Commission may also designate EU reference laboratories where that Member State wishes to have recourse to such a laboratory to ensure the verification of the claimed performance 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.

Note: the number of the article concerning ‘European Union reference laboratories’ may change when the Regulation is published in the Official Journal of the European Union, which is expected to occur in Q1 2017

Financing

EU Reference laboratories may be granted a Union financial contribution.  The EU Commission shall specify by means of implementing acts the structure and level of fees that may be applied for notified bodies or Member States requesting scientific or technical assistance or a scientific opinion from an EU reference laboratory.
Oversight of EU Reference Laboratories
EU Reference Laboratories will be subject to controls, including on-site visits and audits by the Commission to verify compliance with the requirements of the Regulation.

Please find further information in the Appendix page