Technical documentation section 3. Design and manufacturing:

3.5 Outsourced processes

This section describes processes related to the design, manufacture, or other quality-related activities that are performed by external parties on behalf of the legal manufacturer. It provides information on how such outsourced processes are identified, controlled, and monitored to ensure compliance with MDR requirements.

Identification of outsourced processes

All critical processes that are outsourced must be identified, including those related to design, manufacturing steps, testing, sterilization, packaging, labeling, distribution, or any quality assurance activities.

• Description of the outsourced process
• Name and address of the external provider
• Justification for outsourcing

Control and monitoring

The legal manufacturer must demonstrate adequate control over outsourced processes, including qualification of suppliers, contractual agreements, and ongoing monitoring of performance. Documentation should show how the outsourced party meets applicable regulatory and QMS requirements.

• Supplier evaluation and qualification criteria
• Copies or references to supplier agreements
• Records of audits or performance monitoring
• Corrective actions taken, if any

Link to quality management system

Outsourced processes must be integrated into the legal manufacturer's QMS. This includes ensuring the outsourced activities are planned, documented, and reviewed under the QMS framework, with clear responsibilities and interfaces defined.

Changes to outsourced processes

Changes to outsourced processes, including changes in supplier, location, or scope of activities, must be assessed and controlled under the change control procedure. Where applicable, such changes should be reported to the notified body.