How are digital therapeutics regulated in the UK?

DTx are regulated as medical devices under the MHRA. Products require UKCA marking and must conform to Medical Devices Regulations 2002 (as amended). Classification depends on intended purpose: Class I (low-risk decision-support where clinician retains override), Class IIa (software providing diagnosis or direct therapeutic action), or Class IIb (products influencing critical physiological parameters). Manufacturers must demonstrate conformity with Essential Requirements, implement ISO 13485, and maintain post-market surveillance.