The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR).
The Commission explains that harmonized standards do not exist for certain class D IVDs, “and there is a need to address public health concerns as the risk associated with the use of those devices is significant for public health and patient safety.” The Commission notes that some of the common technical specifications previously established for diagnostics under Directive 98/97/EC “remain relevant,” and have, in some cases, been “updated to reflect the state of the art.”
The regulation, Commission Implementing Regulation (EU) 2022/1107, contains 13 annexes, 12 of which set out common specifications for specific types of IVDs. The types of tests covered by the regulation include blood group antigen detection tests for ABO, Rh, Kell, Duffy and Kidd blood group systems, human immunodeficiency virus (HIV), human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis D virus (HDV), Creutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus infection (EBV), Treponema pallidum, Trypanosoma cruzi, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The regulation provides for a transition period from 25 July 2022 until 25 July 2024. During that time, marketed diagnostics that conform with common specifications under Decision 2002/364/EC “shall be presumed in conformity.” Devices that are not in conformity with those common specifications “shall duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.”
“To allow manufacturers, other economic operators, notified bodies and other actors to adapt to this Regulation, and to ensure its proper application, it is appropriate to defer its application,” said the commission. “However, in the interest of public health and patient safety, manufacturers should be allowed to comply with the common specifications laid down in this Regulation on a voluntary basis before its date of application.”
Manufacturers may also conform to the common specifications set out in the new regulation during the transition period.
The regulation also details the general requirements for performance characteristics for the diagnostics covered by the subsequent annexes, including how to determine a device’s performance characteristics, how to resolve discrepant results, whole system failure rate, analytical sensitivity and analytical specificity, analytical and diagnostic specificity, interference and cross-reactivity, batch-to-batch consistency and performances obtained by lay persons.
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