The European Commission issued a regulation which set out some common specifications for high-risk In vitro diagnostics (IVDs) classified as class D under IVDR. This is due to the fact that some of these high risk in vitro diagnostic medical devices do not have harmonized 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 detailed description of performance traits of class D IVDs in the Annexes of the Commission Implementing Regulation.
The European Commission Implementing Regulation 2022/1107, contains 13 Annexes ,12 out of 13 Annexes set out common specification for specific types of IVDs. The tests covered by the regulations include blood group antigen detection test for ABO, Rh, Kell, HIV, HCV, hepatitis B Virus (HBV), HDV, CMV i.e cytomegalovirus, EBV & severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The transition period provided by the European commission regulation is from 25 July2022 until 25 July 2024. It means that European commission has delayed the application date for manufacturer, notified bodies, other economic operators until 25 July 2024, however article 3, contain transitional provisions applies from 25 July 2022. The devices, which are in conformity with the common technical specifications set out in Decision 2002/364/EC in the transition period ,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 followed 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 mentioned IVDR performance characteristics.
Our advice for the manufacturer of above listed medical devices is that they should analyze full text of commission regulation for the details and as a medical device regulatory consultant we assure you that we will resolve the issues associated with these and we will fulfil our clients need with our experience in the field .
References:
https://mdlaw.eu/ivdr/the-european-commission-lays-down-common-specifications-for-class-d-ivds/
