The European Commission has published Commission Regulation (EU) 2022/1107 which lays down Common Specifications (CS) for certain Class D In Vitro Diagnostic (IVD) medical devices in relation to the IVD Regulation 2017/746 (IVDR).
Common Specifications are a set of technical and/or clinical requirements which provide a means of complying with the legal obligations for a particular device, process or system. However, these are not in the same format as standards. Meeting the requirements laid out within Common Specifications means that conformity to the Regulation can be presumed. The publishing of CS has been long awaited in the medical device industry, and it would seem like the Commission is prioritising high risk devices.
The CS described in 2022/1107 will begin to apply from 25 July 2024. However, if a manufacturer were to apply this before, conformity shall be presumed with 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 Regulation (EU) 2017/746. Otherwise, these manufacturers are expected to conform with the common technical specifications which were set out in Decision 2002/364/EC.
In this case, the CS indicate specifications for Class D devices which include devices intended for:
- Detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
- Detection or quantification of markers of human immunodeficiency virus (HIV) infection.
- Detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
- Detection or quantification of markers of hepatitis C virus (HCV) infection.
- Detection or quantification of markers of hepatitis B virus (HBV) infection.
- Detection or quantification of markers of hepatitis D virus (HDV) infection.
- Detection of markers of variant Creutzfeldt-Jakob disease (vCJD).
- Detection or quantification of markers of cytomegalovirus (CMV) infection.
- Detection or quantification of markers of Epstein-Barr virus infection (EBV).
- Detection of markers of Treponema pallidum infection.
- Detection or quantification of markers of Trypanosoma cruzi infection.
- Detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Manufacturers of the above devices will be expected to meet this CS. To do so, they must first apply the general requirements as listed in Annex I of the document, then apply the specifications indicated within their corresponding Annex.
