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CSC-PR-004-Labelling.md

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qms_version 2.2.0
sop_version 2.0.2

Labelling and Available Information SOP

General
Document ID CSC PR.004
Document Version 2.0.2
Author
Approval
QMS Version 2.2.0
Regulatory References UK MDR 2002

Purpose

This document describes the processes for labelling the SaMD and providing information to comply with regulatory standards .

Scope

This procedure must be followed during the development of all CSC computing projects that will directly affect patient care or interact with live clinical system or databases.

Definitions

The following table provides the list of documents to be completed during the design and development phase of the project.

Acronym Definition
SOUP Software of Unknown Provenance - Software used in the project that is not approved by the QMS
QIPS Quality Improvement and Patient Safety
XNAT eXtensible Neuroimaging Archive Toolkit - (imaging informatics platform)
ML Machine Learning
AI Artificial Intelligence
MLOps Machine Learning Operations - (related to DevOps)
PID Patient Identifiable Data
KPI Key performance Indicators
PR Pull Request - Github review action

Roles and Responsibilities

At the start of the project the following roles must be allocated.

Role Responsibility
Clinical Safety Officer Provide expertise and leadership in risk evaluation for the application.
Development lead Generate the labelling information and additional documents
Clinical Lead Provide clinical expertise for labelling and clinical evaluation requirements

1. Method

Under UK MDR 2002, each project must be labelled appropriately to ensure the application is used only as intended and to alert the user of its functionality, associated risks, regulatory compliance.

Within each project the following must be included:

  • Product Name / unique identifier
  • Manufacturer/institution name and address
  • Date of release, and version
  • General description of the application
  • Intended use
  • Foreseeable misuse
  • Warnings and precautions
  • Expected degree of accuracy for the result
  • Work instructions
  • Installation instructions and connecting devices
  • Classification ( MHRA class I, IIa, IIb, III)
  • Clinical investigation (conducted as per Annex X of directive 93/42 Link)

This information must be stored in the project readme, and must include hyperlinks to key technical documentation. It must be reviewed and completed before the deployment.