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Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden 

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  1. In Vitro Diagnostic roadmap
  2. MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector
  3. Clinical trials that include an in vitro diagnostic device
  4. MHRA MedRegs blog – Summer 2025
  5. Exceptional Use Authorisation