MDR QMS requirements
Under the Medical Device Regulation (EU) 2017/745 (MDR), manufacturers are required to establish and maintain a comprehensive Quality Management System (QMS). While certification to standards like ISO 13485:2016 is not explicitly mandated, implementing such a standard is widely recognized as best practice to demonstrate compliance with MDR requirements.
The MDR outlines specific requirements for the QMS, including:
- Systematic and orderly documentation of all elements, requirements, and provisions adopted by the manufacturer for their QMS, including written policies and procedures.
- Documentation enabling a uniform interpretation of the quality policy and procedures, such as quality programs, plans, manuals, and reports.
- Provide a clear definition of the manufacturer’s quality objectives.
- Organizational structures, responsibilities of management personnel, and the organizational authority concerning product manufacturing.
- Methods to ensure the effective operation of the QMS, particularly its capability to achieve the desired product quality, including control over non-conforming products.
- In cases where manufacturing and/or final inspection and testing of products or their components are carried out by third parties, the methods to ensure the effective operation of the QMS, especially the nature and extent of controls applied to these third parties.
- Processes and methods applied, particularly concerning sterilization, procurement, and relevant documentation.
- Product identification methods are established and updated based on drawings, specifications, or other relevant documents at all manufacturing stages.
- Appropriate examinations and tests before, during, and after production, the frequency with which they are conducted, and the testing equipment used. Calibration of the testing equipment must be properly traceable.
Please refer to Annex IX of the MDR for detailed guidance on implementing these requirements and aligning your QMS with MDR standards.