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    Requirements of the Medical Device Regulation (MDR)

    On-demand Training Course

    Requirements of the Medical Device Regulation (MDR)

    Level Understanding Duration 4 hours
    Available to book: On-demand elearning £655 + VAT Book now

    This on-demand course will give you an understanding of the key requirements, which will provide:

    • Essential knowledge to understand Regulatory Affairs of medical devices in the EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
    • The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
    • A basis to learn later about implementation of CE marking projects

    How will you benefit?

    This course will help you:

    • Understand the key requirements and concepts of the European Medical Devices Regulation
    • Communicate the impact of the key requirements introduced by the MDR to your organization
    • By the end of the course, you’ll be able to:

      • Communicate the key requirements and concepts within the Regulation
      • Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
      • Define the vocabulary used within the MDR
      • Explain the structure and administration of the Regulation
      • Recognize partners of manufacturers affected by the Regulation
      • Describe the key steps of a conformity assessment
      • Explain the main impacts on the quality management system (QMS) relating to MDR
      • Recognize the requirements for post-market surveillance and updates
    • The course is especially suitable for:

      • New starters in Regulatory Affairs (RA) and those increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
      • Anyone working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
      • Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.

      Please note: This course will not cover In Vitro Diagnostic Devices. Please refer to the ‘Related training’ below if you need more detailed information e.g. for implementation.

      • This is an online, interactive eLearning course

      On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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