根据98/79/ECC（IVDD）指令附录2确定产品分类原则对有认证需求的产品进行分类。分类的依据是产品所诊断的疾病。常见产品的分类可参考下表：
与上述诊断试剂配套使用的校准品、仪器、标本采集保存用具均属于体外诊断器械指令管理的范畴。
对界于IVDD、MDD和常规仪器之间的产品，可参考欧盟委员会MEDDEV.2.14/1 rev1 “IVD Guidances: Borderline issues”进行分类。
IVD产品欧洲协调标准：
标准号 | 内 容 |
EN375 | Information supplied by manufacturer with IVD for professional use |
EN376 | Information supplied by manufacturer with IVD for self-testing |
EN591 | Instruction for use for IVD instruments for professional use |
EN592 | Instruction for use for IVD instruments for self-testing |
EN12287 | IVD—measure of quantities—description of reference materials |
EN12286 | IVD—measure of quantities—presentation of reference measurement procedures |
EN13532 | General requirements for IVD medical devices for self-testing |
EN13612 | Performance evaluation of IVD medical devices |
EN13641 | Elimination or reduction of risk of infection related to IVD reagents |
DRAFT prEN13975 | Sampling procedures used for acceptance testing of IVD—Statistical aspects |
DRAFT prEN14136 | Use of external quality assessment schemes in the assessment of the performance of IVD procedures |
DRAFT prEN ISO18153 | IVD—measurement of quantities—metrological traceability of values for catalytic concentration of enzymes |
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