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)

FAQs

    • Maintain compliance

    • Improve in quality standards

    • Build confidence within your organisation with competent auditors

    • Motivate colleagues and ensure effective regulatory internal processes

    • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016

    • Individuals interested in conducting first-party or second-party audits

    • Management representatives

    • Internal auditors

    • Consultants