In the document European Commission explains that for certain class D IVDs harmonised standards do not exist and since the risk associated with the use of those devices is significant for public health and patient safety, it is appropriate to adopt common specifications for those devices. Commission also states that the common technical specifications previously established for certain devices covered by Directive 98/79/EC remain relevant, but are updated where necessary to reflect the state of the art.
As defined by Regulation (EU) 2017/746 ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Commission Implementing Regulation (EU) 2022/1107 contains 13 annexes. Annex 1 lays down general common specifications as ‘Requirements for performance characteristics of devices’ presented in two parts and the rest of 12 annexes set out common specifications for specific types of IVDs, which are; blood group antigen detection devices for ABO, Rh, Kell, Duffy and Kidd blood group systems, devices for detection or quantification of markers of human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), 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.
This Regulation shall apply from 25 July 2024. During the period from 25 July 2022 until 25 July 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. 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Click here for more information.
Do you need additional knowledge or assistance in meeting the requirements of MDR/IVDR?
With the help of our actual educations and consulting services, we can help you meet the requirements of the MDR/IVDR.
Resource: