Technical documentation section 1. Device description and specifications:

1.3 Intended purpose of medical device

The Intended Purpose/Intended Use document in a technical file follows a structured format that includes essential regulatory and functional details about the medical device. The document typically consists of the following sections:

1. Document identification and approval details

• Document title: "Intended Purpose" or "Intended Use"
• Document ID: Unique identifier for tracking
• Version number: Current document version
• Effective date: Date when the document became valid
• Approvals: Signatures and roles of originator, reviewer, and approver
• Revision history: Log of version updates with dates and comments

2. Identification of the medical device

• Product name
• General description of the device
• Category of the device (e.g., software-based, electromechanical, disposable, sterile/non-sterile)
• Explanation of the device’s role in medical practice

3. Intended purpose or intended use

• Definition of the intended function of the device within clinical practice
• Clinical applications the device supports
• How the device interacts with the patient or user (e.g., imaging, data processing, physical interaction)
• Key features supporting its intended purpose
• Any limitations or exclusions regarding its use

4. Specification of the main function

• Description of the core functional role of the device
• Explanation of how it achieves its primary objective (e.g., processing images, restoring speech, acting as a barrier)

5. Specification of the main functional field

• Categorization as per regulatory classification (e.g., sterile vs. non-sterile, active vs. passive, measuring vs. non-measuring)
• Description of the medical environment where the device is used (e.g., hospitals, home care, laboratories)

6. Measured parameters (if applicable)

• If the device involves measurement, a list of specific parameters it evaluates (e.g., dimensions in imaging, pressure levels in medical gloves, vibration frequency in electrolarynx)

7. Description of method and working principle

• Scientific or technical explanation of how the device operates
• Software or hardware mechanisms that enable its function
• Description of any interaction with external systems (e.g., PACS integration for imaging software)

8. Indications for use

• Clinical scenarios where the device should be used
• Target medical procedures or applications
• Specific conditions or diseases the device addresses

9. Contraindications, limitations, or restrictions

• Situations where the device should NOT be used
• Limitations regarding patient conditions or medical settings
• Potential misuse cases or risks

10. Patient population

• Clarifies whether there are any demographic restrictions
• Includes details like:
  • Sex: relevant/not relevant
  • Age: relevant/not relevant
  • Health status: specific conditions or unrestricted
  • Physical characteristics: if any restrictions apply

11. User profile

• Who is authorized to use the device? (e.g., healthcare professionals, trained technicians, or patients themselves)
• Any necessary training or expertise required

12. Warnings and precautions

• Specific risks or safety warnings
• Proper handling and usage instructions
• Notes on regulatory compliance (e.g., GDPR for software, ISO standards)