Technical documentation section 1. Device description and specifications:

1.6 Operating principles and mode of action

The Operating Principles and Mode of Action section of the technical documentation provides a structured explanation of how a medical device functions, detailing its core mechanisms, workflow, and interaction with users and systems. It ensures regulatory transparency by outlining the device’s intended use, operational principles, key features, and compliance with relevant standards.

1. General information

• Document Title: Operating Principles and Mode of Action
• Document ID: A unique identifier assigned to the document
• Version Number: Specifies the version of the document to track revisions
• Effective Date: The date from which the document is applicable
• Approvals: Includes roles such as Originator, Reviewer, and Approver along with names, departments, and signatures

2. Scope and purpose

This section defines the purpose of the document and its relevance to the medical device. It typically:

• Provides an overview of the device's intended application
• Explains why understanding its operating principles is essential for safe and effective use
• Establishes the link between the device’s functionality and its role in healthcare settings

3. Operating principles

This section outlines the fundamental working mechanisms of the device. Depending on the type of device, it may cover:

3.1 Interaction with the user and environment

• Explanation of how the device is operated by users (e.g., healthcare professionals or patients)
• Description of key functions that facilitate its intended use

3.2 Core functionalities

• Detailed description of the main principles governing the operation
• Key technical components or mechanisms enabling the device to perform its intended function
• Any automation or enhancements that improve performance

3.3 Compliance with standards

• Description of how the device adheres to relevant regulatory and safety standards (e.g., MDR, ISO)

4. Mode of action (workflow)

This section details how the device operates within a structured workflow, from initialization to final outcome.

4.1 Activation and initialization

• How the device is prepared for use (e.g., power-up sequence, self-checks)

4.2 Operational phases

• Step-by-step description of how the device executes its primary function
• Any intermediate steps involved in processing, monitoring, or data acquisition

4.3 Final output and actions

• The results produced by the device (e.g., images, measurements, reports)
• Interaction with other systems (e.g., data transmission, integration with hospital networks)

4.4 User interaction and controls

• How users can interact with the device, adjust settings, or interpret output

5. Key functional features

This section highlights the core features that enhance the device's usability and performance.

• Automated functions (e.g., image enhancement, real-time monitoring)
• User safety features (e.g., access controls, alerts)
• Data security and compliance (e.g., encryption, role-based access)
• Integration capabilities (e.g., compatibility with hospital IT systems)

6. Confidentiality and circulation

A standard confidentiality clause is included to control document distribution. It typically states that:

• The document is intended for internal use within the manufacturer’s organization
• It must not be shared with third parties without explicit written permission