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EU Medical Device Regulation 2017/745 (EU MDR)

EU Medical Device Regulation 2017/745 (EU MDR)

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 OBJECTIVES

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)

 

TARGET AUDIENCE
  • 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
COURSE BENEFITS 
  • Maintain compliance
  • Improve in quality standards
  • Build confidence within your organisation with competent auditors
  • Motivate colleagues and ensure effective regulatory internal processes