On July 4th, 2022, the European Commission adopted “Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council”.
This implementing regulation lays down common specifications in respect of the requirements regarding the performance characteristics set out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to the IVDR.
The regulation lays down common specifications for:
- devices covered by Annexes II to XIII Annex (Annex I)
- devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems (Annex II)
- devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection (Annex III).
- devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection (Annex IV).
- devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection (Annex V).
- devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection (Annex VI).
- devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection (Annex VII).
- devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD) (Annex VIII).
- devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection (Annex IX).
- devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV) (Annex X).
- devices intended for detection of markers of Treponema pallidum infection (Annex XI).
- devices intended for detection or quantification of markers of Trypanosoma cruzi infection (Annex XII).
- devices intended for detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (Annex XIII).
These specifications will enter into force on 25 July 2022 and will apply from 25 July 2024. However, devices that are in conformity with the common technical specifications for IVDs set out in Decision 2002/364/EC will be considered to be in conformity with the requirements regarding the performance characteristics set out in Section 9.1, points (a) (analytical performance) and (b) (clinical performance), Section 9.3 (reference measurement procedures for calibrators and/or control materials) and Section 9.4, point (a) (self-test devices use with laypersons), of Annex I to the IVDR.
What does this mean to you?
If you manufacture Class D devices that fall within any of the above categories, review the common specifications carefully to identify what you need to do for your products specifically. You will either need to demonstrate conformity to the existing common technical specifications or justify your alternative measures, with the date of application for these new common specifications coming on 25 July 2024.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
