EU Medical Device Regulation 2017/745 (EU MDR)

EU Medical Device Regulation 2017/745 (EU MDR)(1 day)

This course aims to provide learners who have an existing, basic knowledge of, or experience in,quality management in the Medical Device Industry with an in-depth understanding of the application under the European Union’s Medical Device Regulation (EU-MDR 2017/745) Regulation.

Topic areas: Medical device quality management systems, the European Union’s Medical Device Regulation (EU MDR) and audit considerations.

Course Duration: 1 Day
Delivery Method: Online

What will I learn?

On completion of this training, participants will be able to:

  • Understand the history, purpose, and structure of the EU-MDR, and the key terminology used throughout the regulation, and identify the types of devices covered by the EU-MDR and the rules for classifying these devices.
    • Describe the obligations of the economic operators and the Person Responsible for Regulatory Compliance (PRRC).
    • Describe and demonstrate understanding of the General Safety & Performance Requirements (GSPRs) and the key features of a risk management system based on ISO 14971.
    • Describe the contents of the technical documentation and demonstrate understanding of the requirements for post-market surveillance, vigilance, and clinical data.
    • Explain the Unique Device Identifier requirements and the relationship with European Electronic Database (EUDAMED)

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