European Regulations and Directives

European Regulations and Directives

Principal Regulations: IVD and MD

Principal Directives: IVD, MD and AIMD

Implementing Regulations and Decisions

Other Directives and Regulations

Commission Recommendations

Common Technical Specifications

Commission Implementing Decision 2019/1244 amending Decision 2002/364/EC Requirements for HIV and HCV antigen and antibody combined tests and requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays Download (382 KB) »
Commission Implementing Decision 2020/350 amending Decision 2002/364/EC Definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays Download (522 KB) »


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