Common specifications ThisRegulation lays down common specifications for certain classD in vitro diagnostic medicaldevices in respect of the requirements regarding the performancecharacteristics set outin Section 9.1, points (a) and (b), Section 9.3 and Section 9.4,point (a), of Annex I to Regulation(EU) 2017/746.
通用规范本法规针对第2017/746号法规（EU）附件一第9.1节第（a）点和第（b）点、第9.3节和第9.4节第（a）点中规定的性能特征要求，制定了某些D类体外诊断医疗器械的通用规范。
AnnexI lays down common specifications for devices covered by Annexes IIto XIII, as specifiedin that Annex.
AnnexII lays down common specifications for devices intended fordetection of blood group antigensin the ABO, Rh, Kell, Duffy and Kidd blood groupsystems.
AnnexIII lays down common specifications for devices intended fordetection or quantificationof markers of human immunodeficiency virus (HIV)infection.
AnnexIV lays down common specifications for devices intended fordetection or quantificationof markers of human T-cell lymphotropic virus (HTLV)infection.
AnnexV lays down common specifications for devices intended fordetection or quantificationof markers of hepatitis C virus (HCV) infection.
AnnexVI lays down common specifications for devices intended fordetection or quantificationof markers of hepatitis B virus (HBV) infection.
AnnexVII lays down common specifications for devices intended fordetection or quantificationof markers of hepatitis D virus (HDV) infection.
AnnexVIII lays down common specifications for devices intended fordetection of markers of variantCreutzfeldt-Jakob disease (vCJD).
AnnexIX lays down common specifications for devices intended fordetection or quantificationof markers of cytomegalovirus (CMV) infection.
AnnexX lays down common specifications for devices intended fordetection or quantificationof markers of Epstein-Barr virus infection (EBV).
AnnexXI lays down common specifications for devices intended fordetection of markers of Treponemapallidum infection.
AnnexXII lays down common specifications for devices intended fordetection or quantificationof markers of Trypanosoma cruzi infection.
AnnexXIII lays down common specifications for devices intended fordetection or quantificationof markers of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection.
IVDEAR团队还可承接新冠变异株BA.4,BA.5和BA.2.75的临床实验研究、新冠前瞻性临床实验研究（含伦理批文）以及以下检测试剂：梅毒、血糖、PSA、HIV、流感、水痘、尿酸、验孕等常见产品的临床实验研究项目。
