EU Medical Device Regulation (MDR) 2017/745 Fundamentals Training Course

This practical and interactive 2-day course focuses on what is required to bring a Medical Device to market under Medical Device Regulation (EU) 2017/745 (MDR).

On April 5, 2017, the Medical Device Regulation (EU) 2017/745 replaced the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The Medical Device Regulation entered into force on May 25, 2021, after a four-year transition period. EU MDR compliance is accomplished by demonstrating conformity with all relevant aspects of the Medical Device Regulation (EU) 2017/745. Manufacturers will need to demonstrate compliance to gain regulatory approval of their medical devices.

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

• Understand the history, purpose and structure of the MDR
• Understand the transition period to the new MDR
• Be able to identify the types of devices covered by the MDR and the rules for classifying these devices.
• Be able to identify the key steps in conformity assessment and the role of Notified Bodies
• Describe the roles and responsibilities of the manufacturer, Economic Operators and the Personnel Responsible for Regulatory Compliance (PRRC)
• Understand requirements for post-market surveillance, post-market clinical follow-up and vigilance.
• Explain the quality management system requirements in the MDR
• Understand the Unique Device Identification (UDI) requirements and the purpose of EUDAMED database

This course is for medical device organizations who need a foundation in the EU MDR, specifically:

• • Personnel working in the Medical Device Industry
  • Anyone new to the Medical Device Industry
  • Personnel in quality management
  • Research and design engineers
  • Manufacturing engineers
  • Regulatory professionals