Technical documentation section 1. Device description and specifications:

1.7 Raw materials, components, packaging materials

The technical documentation for raw materials, components, and packaging materials provides a comprehensive overview of the materials used in the production of the medical device. It ensures regulatory compliance by documenting material properties, sources, and specifications, along with their relevance to the device’s function and safety.

1. General information

• Document title: Raw materials, components, packaging materials
• Document ID: A unique identifier assigned to this document
• Version number: Specifies the document’s revision history
• 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 role in ensuring quality and safety in device manufacturing. It typically:

• Provides a structured identification of raw materials, components, and packaging materials
• Ensures traceability and compliance with regulatory standards
• Facilitates risk management by defining the characteristics of materials used in the device

3. Identification of raw materials, components, and packaging materials

This section categorizes the materials involved in device manufacturing, outlining their properties and reference documentation.

3.1 Raw materials

• Identification of core raw materials used in production
• Material properties, including chemical composition and physical characteristics
• Reference documents such as Certificates of Analysis and Safety Data Sheets

3.2 Components

• Key structural and functional components of the device
• Material specifications and supplier documentation
• Details on how components contribute to device functionality

3.3 Packaging materials

• Identification of packaging types and their specifications
• Material properties, including composition and durability
• Special considerations such as sterility, recyclability, and compliance with safety standards

4. Compliance with standards

This section outlines how raw materials, components, and packaging materials adhere to regulatory requirements and industry standards.

• Compliance with applicable safety and performance standards (e.g., MDR, ISO)
• Traceability requirements for raw materials and components
• Validation and testing protocols for material suitability

5. Storage and handling requirements

Proper storage and handling of raw materials and components ensure their integrity and performance.

• Environmental conditions required for material preservation
• Storage instructions to maintain material quality and prevent contamination
• Special handling considerations for sensitive or hazardous materials

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