Regulatory Information

Manufacturer

Cadence Health Ltd
3rd Floor, 86-90 Paul Street
London, EC2A 4NE
United Kingdom

Regulatory contact

regulatory@cadencehealth.uk

Person Responsible for Regulatory Compliance

Bradley Phelps

Device classification

MHRA Class I medical device (Software as a Medical Device)

Registration details

  • DORS registration reference: 2026031601473996
  • Account reference: 0000037736
  • GMDN code: 64275 — Patient general health self-management software
  • Applicable regulation: UK Medical Devices Regulations 2002 (SI 2002/618), Part II

Intended purpose

Nudge is an information and behaviour-support tool for patients prescribed GLP-1 receptor agonist medications (tirzepatide, semaglutide). It provides:

  • Educational content about medication effects and injection cycles
  • Symptom and wellbeing tracking
  • Nutrition guidance
  • Adherence support

Nudge does not provide clinical advice, diagnosis, dose recommendations, or replace the judgement of a healthcare professional.

Standards applied

  • ISO 14971:2019 — Risk management
  • IEC 62304:2006+A1:2015 — Software lifecycle (Safety Class B)
  • IEC 62366-1:2015 — Usability engineering
  • DCB0129 / DCB0160 — NHS clinical risk management

UKCA marking

UKCA conformity mark

Declaration of Conformity

Available on request from regulatory@cadencehealth.uk.