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MHRA Issues Guidance on Self-Test Kits

January 2, 2013
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance for consumers on how to use self-test kits for fertility, sexually transmitted diseases and cancer. The Q&A guidance notes that kits should be CE-marked, sold by a reputable source and not be used in place of physician consultations.
International Medical Device Regulatory Monitor