European Commission Adopts Common Specifications for High-Risk Diagnostics
On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal of clarifying the requirements for market actors and protecting EU patients.
Article 3 of the new specifications lays out a transitional period: From July 25, 2022, to July 25, 2024, devices that are in conformity with the common technical specifications set out in Decision 2002/364/EC shall be presumed to be in conformity 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.
During that period manufacturers of devices that are not in conformity with the common technical specifications set out in Decision 2002/364/EC “shall duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.”
The common specifications outlined in the new regulations cover performance characteristic requirements of certain class D in vitro diagnostic medical devices including:
- devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
- devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection.
- devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
- devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection.
- devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection.
- devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection.
- devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD).
- devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection.
- devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV).
- devices intended for detection of markers of Treponema pallidum infection.
- devices intended for detection or quantification of markers of Trypanosoma cruzi infection.
- devices intended for detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
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