Healing Process policy suite

Medical Device Status and Intended Purpose Policy

1. Purpose

To ensure that Healing Process claims, design, evidence, quality management, market placement and change control remain consistent with a documented intended purpose and the applicable UK medical-device regulatory position.

2. Scope and status

This policy applies to product strategy, website and sales claims, app-store content, software requirements, algorithms, pilots, clinical investigations, customer contracts, labels, instructions, post-market activity and decommissioning.

Core supplier and product policy

3. Policy principles

• Regulatory status is determined by intended purpose and functionality, not by calling the product “wellness”, “support” or “non-diagnostic” while providing a medical function.
• The intended purpose must be precise enough to guide classification, risk management, evidence, usability, cybersecurity and post-market monitoring.
• No worker may expand claims informally in a demonstration, proposal, screenshot or training session beyond the approved claims register.
• A pilot is not a regulatory exemption. The legal route for clinical investigation, service evaluation, research or lawful supply must be established before use.

4. Mandatory requirements

• Maintain an approved intended-purpose statement identifying users, population, condition or process, setting, inputs, outputs, intended medical or non-medical benefit, exclusions and limits.
• Obtain competent regulatory assessment and, where uncertainty remains, seek appropriate specialist or regulator advice while retaining independent legal responsibility.
• Maintain a claims register mapping every public and contractual claim to evidence, status and approved wording.
• Assess device classification and conformity route, quality-management needs, technical documentation, clinical evidence, registration, labelling, vigilance and post-market duties where the product is a medical device.
• Control promotional wording such as “detects deterioration”, “determines better or worse”, “triages”, “diagnoses” or “recommends treatment”; these may materially alter intended purpose and cannot be used without approval and evidence.
• Review third-party and customer-created descriptions and require correction where they misstate status or function.
• Perform regulatory impact assessment for every material change to algorithm, user, population, output, workflow, integration, evidence or market.
• Keep a clear boundary between demonstrator screens and available, approved production functionality.

5. Procedure and escalation

• The Regulatory Lead reviews concepts before development commitment and approves claims before publication.
• A proposed clinical study is categorised and routed to the appropriate approvals, including ethics and MHRA notification where applicable, before recruitment or device use.
• Non-conforming or misleading claims are withdrawn promptly, affected customers are informed where necessary and corrective action is recorded.
• Product retirement includes regulatory records preservation, customer communication, vigilance continuity and registration updates where required.

6. Roles and responsibilities

Regulatory Lead

owns status, intended purpose, classification, claims and regulator interaction.

Clinical/Product leads

ensure requirements and evidence match the intended purpose.

Marketing/Sales

use only approved claims and current status wording.

Quality lead

maintains controlled documentation, change and post-market processes.

Providers

use the product only for contracted, approved purposes and do not locally relabel it without governance.

7. Records, confidentiality and retention

Retain regulatory assessments, advice, intended-purpose versions, claims register, classification, technical/evidence index, approvals, registrations, labels, complaints, vigilance and change decisions for the required period.

Records created under this policy must be accurate, attributable, access-controlled and linked to the applicable retention schedule. Where a provider is the controller or authoritative record holder, its documented instructions and legal duties apply.

8. Monitoring, assurance and review

Review at least annually and before every material claim, study or product change. Audit public content, proposals, demonstrations and customer materials against the claims register.

Material non-compliance is reported through the relevant clinical-safety, patient-safety, data, security, safeguarding, HR, contractual or whistleblowing route. Corrective actions receive an owner, target date and effectiveness check.

9. Training and communication

The policy owner identifies which roles require awareness, operational or specialist training. Training is accessible, version-controlled, role-specific and refreshed after material change or evidence that understanding is inadequate. Providers communicate local procedures and contact routes before users are granted access.

10. Related documents

• Clinical Safety Policy
• AI Image Policy
• Research and Evaluation Policy
• News and Content Governance Policy

11. Approval record