Medical Device Regulation (MDR): Guide and introductory aid for manufacturers and suppliers

developed by VDMA HealthTech and Metecon

(Please note: The guide is available only in German. However, you can easily translate the PDF using standard online translation tools for better accessibility.)

The MDR demands increased transparency, new responsibilities, and closer collaboration. Our guide with VDMA HealthTech offers practical insights for better understanding and successful cooperation.

Table of contents:

  • Quality Management System (QMS):
    • Importance for manufacturers / Importance for suppliers
    • Commonly required documents
  • Development / Design / Engineering:
    • Requirements for safe and effective designs
    • Importance of collaboration between manufacturers and suppliers
  • Risk Management:
    • Integration of suppliers into risk management
    • Joint development of risk mitigation measures
  • Manufacturing:
    • Detailed documentation of all used substances
    • Validation and documentation of manufacturing processes
  • Glossary

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