Declaration of Conformity

Document reference: DoC-CADENCE-001 v0.5 · Date: 2026-03-20

Manufacturer

Device Identification

• Device name: Cadence
• Software version: 1.4.0
• GMDN code: 64275 — Patient general health self-management software
• Classification: Class I (non-measuring, non-sterile)
• Applicable regulation: UK Medical Devices Regulations 2002 (SI 2002/618, as amended), Part II, Annex IX

MHRA Registration

• DORS registration reference: 2026031601473996
• Account number: 0000037736
• Registration date: 2026-03-16

Intended Purpose

Cadence is a software application that provides educational and behavioural support content for adult patients (18+) prescribed GLP-1 receptor agonist medications (tirzepatide or semaglutide) for weight management. The software delivers pharmacokinetically-grounded daily content, symptom tracking, and self-management support across a 52-week treatment programme.

Cadence does NOT: provide medical diagnoses, recommend or suggest dose changes, perform automated clinical risk assessment, or replace clinical judgement. All content is informational and supportive in nature.

Essential Requirements

This device conforms with the applicable Essential Requirements of Annex I to the UK Medical Devices Regulations 2002 (Part II), as documented in the Technical File (§03 Essential Requirements Checklist).

Applied Standards

Safety Classification

• IEC 62304 software safety class: B
• Clinical risk: Residual risk acceptable (Technical File §04)
• Benefit-risk: Favourable (Technical File §07)

Declaration

I, Bradley Phelps, as the Person Responsible for Regulatory Compliance for Cadence Health Ltd, hereby declare that the device described above conforms with the applicable provisions of the UK Medical Devices Regulations 2002 (SI 2002/618, as amended).

This declaration is issued under the sole responsibility of the manufacturer.