The European Commission lays down common specifications for Class D IVDs! · MDlaw – Information platform on European medical device regulations

The European Commission has adopted the Commission Implementing Regulation setting out common specifications for some IVDs classified as Class D under the In Vitro Devices Regulation 2017/746, such as devices detecting HIV, HBV, SARS-CoV-2. This is due to the fact that some of these high risk in vitro diagnostic medical devices do not have harmonised standards developed covering certain provisions of IVDR Annex I . Therefore, ‘’to set uniform and rigorous benchmarks for tests across the EU, for greater clarification of requirements to market actors and to protect patients’’, the European Commission presents a very detailed description of performance characteristics of class D IVDs in the Annexes of the Commission Implementing Regulation.

Specific categories of devices are covered by Annex II to Annex XIII, while Annex I enlists the general common specifications linked to the IVDR of which we can highlight, among others, the following requirements for performance characteristics:

Batch-to-batch consistency

8.	For devices intended to detect antigens and antibodies, the manufacturer’s batch testing criteria shall ensure that every batch consistently identifies the relevant antigens, epitopes, and antibodies and is suitable for the claimed specimen types.

9.	The manufacturer’s batch release testing for first-line assays shall include at least 100 specimens negative for the relevant analyte (1). (…)

Analytical and diagnostic sensitivity

10.

Devices intended by the manufacturer for testing body fluids other than serum or plasma, e.g. urine, saliva, etc., shall meet the same requirements as serum or plasma devices. The manufacturer shall test specimens from the same individuals in both the devices to be approved and in a respective serum or plasma device. (2)

11.	Devices for self-testing shall meet the same requirements as respective devices for professional use. (…)

In addition to this, the following Annexes state common specification for certain types of devices:

Annex II: common specifications for devices intended for detection of blood group antigens in the BO, RH, Kell, Duffy and Kidd blood group systems;
Annex III: common specifications for devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection;
Annex IV: common specifications for devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection;
Annex V: common specifications for devices intended for detection or quantification of markers of Hepatitis C virus (HCV) infection;
Annex VI: common specifications for devices intended for detection or quantification of markers of Hepatitis B virus (HBV) infection;
Annex VII: common specifications for devices intended for detection or quantification of markers of Hepatitis D virus (HDV) infection;
Annex VIII: common specifications for devices intended for detection of markers of variant Creutzfeldt-Jacob (vCJD) disease;
Annex IX: common specifications for devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection;
Annex X: common specifications for devices intended for detection or quantification of markers of Epstein-Barr virus (EBV) infection;
Annex XI: common specifications for devices intended for detection of markers of Treponema pallidum infection;
Annex XI: common specifications for devices intended for detection or quantification of markers of Trypanosoma cruzi infection;
Annex XIII: common specifications for devices intended for detection or quantification of markers of severe acute respiratory syndrome Coronavirus 2 infection;

On these annexes, the implementing regulation focuses on different aspects, from diagnostic specificity, to cross-reactivity or analytical sensitivity.

Timeline

To allow manufacturers, other economic operators, notified bodies and other actors to adapt to this Regulation, the European Commission has delayed the application date until 25 July 2024. However, Article 3, which contains transitional provisions applies from 25 July 2022. This provision grants devices, which are in conformity with the common technical specifications set out in Decision 2002/364/EC in the period between 25 July 2022 and 25 July 2024 to presume 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 IVDR Annex I.

Manufacturers not applying common technical specifications as per the Decision 2002/364/EC shall justify that they have adopted solutions to ensure an equivalent level of safety and performance.

At the same time, the transitional provision of the Commission Regulation permits the manufacturers to already follow the ”new” common specifications and presume conformity to the above mentioned IVDR performance characteristics.

We highly advise manufacturers producing any of the above listed devices, to already analyze the full text of the Commission Regulation, which is available in our dedicated Library of documents – IVDR Common Specifications.

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