Technical documentation section:
3. Design and manufacturing section of technical documentation
The design and manufacturing section of MDR-compliant technical documentation provides detailed information on how the medical device is developed, engineered, and produced. This section is essential for demonstrating conformity with the general safety and performance requirements set out in Annex I of the MDR.
Design process
The technical documentation must describe the structured and traceable design process, starting from initial concept through to final design outputs. This includes design planning, risk management integration, user needs assessment, functional and performance specifications, design verification and validation, as well as any design changes throughout the development cycle.
Design outputs
This part outlines the final design specifications, drawings, materials, components, and software elements, where applicable. It should also explain how these outputs fulfill the intended use and safety requirements of the device.
Manufacturing processes
A detailed description of the manufacturing procedures is required, including process controls, critical steps, and quality checks. This includes methods of sterilization, packaging, and labeling, where relevant. Manufacturing sites and subcontractors involved in production should be identified and documented.
Process validation and controls
The documentation must include evidence of validated processes for manufacturing, particularly for steps that cannot be fully verified through final inspection. Examples include sterilization, welding, and molding. All control measures must demonstrate compliance with the QMS and applicable harmonized standards.
Change management
This section should describe how design and manufacturing changes are controlled, assessed, and documented. The impact of any changes on safety, performance, and regulatory compliance must be evaluated in accordance with the QMS procedures.
Below, you will find links to information about the documents included in Section 3 of MDR-compliant technical documentation, covering key requirements for development and manufacturing of medical devices.
