The EU IVD Regulation

For more than a decade, GeneWatch UK has exposed companies making misleading claims about genetic test results (see Genes and marketing). Academics and the US Government Accountability Office (GAO) have also found many companies making misleading claims about genetic test results and people's risk of future illness. The EU's new IVD (In-Vitro Diagnostics) Regulation will regulate medical tests, including genetic tests.

The EU Regulation includes genetic tests used to predict future illness or drug response in its scope, including computer algorithms that combine multiple genetic and non-genetic factors to make personalised risk predictions. The regulation will protect patients and consumers by requiring companies to provide evidence that genetic tests and computer algorithms correctly diagnose or predict disease, before they can be marketed. However the regulations will not come into force until 2022. Read the GeneWatch UK briefing about the EU's In Vitro Diagnostics (IVD) Regulation.

The UK Medicines and Healthcare Regulatory Agency (MHRA) is preparing to implement the regulations into UK law, however it remains unclear whether or not all the regulations will apply following Brexit.


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