This regulation lays down common specifications for certain class D IVD products in respect of the requirements regarding the performance characteristics set out in the IVDR, including:
- Annex I:
General Common Specifications
- Annex II:
For Devices Intended for Detection of Blood Group Antigens in the ABO, Rh, Kell, Duffy and Kidd Blood Group Systems
- Annex III:
For Devices Intended for Detection or Quantification of Markers of Human Immunodeficiency Virus (HIV) Infection
- Annex IV: For Devices Intended for Detection or Quantification of Markers of Human T-Cell Lymphotropic Virus (HTLV) Infection
- Annex V:
For Devices Intended for Detection or Quantification of Markers of Hepatitis C Virus (HCV) Infection
- Annex VI:
For Devices Intended for Detection or Quantification of Markers of Hepatitis B Virus (HBV) Infection
- Annex VII:
For Devices Intended for Detection or Quantification of Markers of Hepatitis D Virus (HDV) Infection
- Annex VIII:
For Devices Intended for Detection of Markers of Variant Creutzfeldt-Jacob (vCJD) Disease
- Annex IX:
For Devices Intended for Detection or Quantification of Markers of Cytomegalovirus (CMV) Infection
- Annex X:
For Devices Intended for Detection or Quantification of Markers of Epstein-Barr Virus (EBV) Infection
- Annex XI:
For Devices Intended for Detection of Markers of Treponema Pallidum Infection
- Annex XII:
For Devices Intended for Detection or Quantification of Markers of Trypanosoma Cruzi Infection
- Annex XIII:
For Devices Intended for Detection or Quantification of Markers of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
For more details, please click the link below to find the full articles of the implementing regulation.