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!


Implementing Regulations and Decisions

Common Technical Specifications

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

Don’t hesitate to contact us if you need help with the interpretation with one of these documents!