From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16 September 2024, stakeholders can submit their feedback on addressing requirements for class D requirements according to the EU Regulation on IVDs (IVDR).
Common specifications for class D IVDs
For certain requirements set by the IVDR, there are no harmonised standards for class D devices intended for detection of hepatitis E virus, Toxoplasma gondii, Plasmodium spp., as well as four types of arboviruses (Chikungunya virus, dengue virus, West Nile virus and Zika virus). Therefore, the Commission considers appropriate to add common specifications for these devices. Moreover, there is need to further clarify some aspects of already existing common specifications, taking into consideration their use so far. In order for the industry to adapt to the new requirements, transitional period is envisaged in the draft act.
The Commission consulted the MDCG Group (Medical Device Coordination Group) and drafted measures in accordance with the Committee on Medical Devices’ opinion, which would be implemented according to transitional provisions.
Draft common specifications and related Annex
Draft common specifications and related Annex address devices covered by Annexes II to XX, as described in Annex I as well as class D devices intended for the detection (or quantification) of:
- Blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems
- Markers of human immunodeficiency virus (HIV) infection
- Markers of human T-cell lymphotropic virus (HTLV) infection
- Markers of hepatitis C virus (HCV) infection
- Markers of hepatitis B virus (HBV) infection
- Markers of hepatitis D virus (HDV) infection
- Markers of variant Creutzfeldt-Jakob disease (vCJD)
- Markers of cytomegalovirus (CMV) infection
- Markers of Epstein-Barr virus infection (EBV)
- Markers of Treponema pallidum (T. pallidum) infection
- Markers of Trypanosoma cruzi (T.cruzi) infection
- Markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Markers of hepatitis E virus (HEV) infection
- Markers of Toxoplasma gondii infection
- Markers of Plasmodium infection
- Markers of Chikungunya virus (CHIKV) infection
- Markers of dengue virus (DENV) infection
- Markers of West Nile virus (WNV) infection
- Markers of Zika virus (ZIKV) infection
Lastly, there is also newly replaced text defining ”virus typing device” meaning a device used for typing with already known positive specimens, not used for primary diagnosis of infection or for screening.
Stakeholders can submit their feedback here.
More information in our Library of Documents dedicated to IVDs’ public consultations.
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