A collection of European Regulations and Directives.
Hereunder, you can download the European Regulations and Directives that are relevant for Medical Devices and In Vitro Diagnostic Medical Devices.
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European Regulation 2017/746 on In Vitro Diagnostic Medical Devices
Published May 5, 2017 – Consolidated version
European Regulation 2017/745 on Medical Devices
Published May 5, 2017 – Consolidated version
European Directive 90/385/EEC on Active Implantable Medical Devices
Consolidated version 2007
European Directive 93/42/EEC on Medical Devices
Consolidated version 2007
European Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Consolidated version 2012
Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)
Consolidated version 2018-07-04
Directive 2006/42/EC on Machinery
Consolidated version 2019-07-26
Regulation 1907/2006 on Registration, Evaluation, Authorization & Restriction of Chemicals (REACH)
Consolidated version 2020-02-27
Directive 2011/65/EU RoHS on restriction of use of hazardous substances in electronic equipment
Consolidated version 2020-05-01
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
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
Commission Decision 2002/364/EC on Common Technical Specifications for In Vitro Diagnostics (CTS)
Consolidated version 2012-07-01
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