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.
If you want to receive document updates and other regulatory news immadiately in your mailbox, subscribe to our newsletter!
European Regulation 2017/746 on In Vitro Diagnostic Medical Devices
Published May 5, 2017 – Consolidated version
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
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
Don’t hesitate to contact us if you need help with the interpretation with one of these documents!