Question
Why are MyBody-X style tests not subject to the EU Medical Device Regulation (MDR)?
Health · EN
Why are MyBody-X style tests not subject to the EU Medical Device Regulation (MDR)?
Review status disclosedPublic · privacy gate
TIKKI knowledge answer
In the EU, MyBody-X style tests are classified as informational or wellness products and fall outside the Medical Device Regulation (MDR) because they do not claim to diagnose, treat, or prevent disease.
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