Essentials of European Medical Device Regulations

Essentials of European Medical Device Regulations

245 STUDENTS ENROLLED

Course Overview

Understand the essential requirements and concepts of the European Medical Devices Regulation, with the Essentials of European Medical Device Regulations course. This course covers the essential components of EU MDR, taking you through regulatory changes in the European market, the structure of the regulation and the partners affected by it. It includes important information on reporting requirements and identification, as we as an overview of  the UK Guides to Good Manufacturing Practice.

Key Topics to Be Covered

  • What is EU MDR?
  • An overview of the essential components of EU MDR
  • Reporting Requirements and Identification
  • The UK Guides to Good Manufacturing Practice
  • Regulatory Changes in the European Market
  • Certification bodies and accreditation

Learning Outcomes

  • Deepen your understanding of the EU Medical Devices Regulations and how it can be applied 
  • Learn about recent regulatory changes in the European market
  • Understand what EU MDR means in practice
  • Have an excellent understanding of reporting requirements and identification
  • Gain in-depth knowledge of how the new regulations affect medical device manufacturers, importers, distributors and EU Representatives
  • Understand the complete process for CE marking under the Medical Devices Regulation (MDR)

Your Path to Success

On successful completion of this course, you will have up-to-date knowledge of the core requirements and concepts of the EU Medical Devices Regulations, the essential components of EU MDR, and regulatory changes in the European market. 

Skills You Will Gain

  • Competency in your field
  • Up-to-date knowledge on EU MDR
  • Expertise in clinical evaluation

Course Curriculum

Essentials of European Medical Device Regulations
Module 1: Overview to European Regulations on Medical Devices 00:43:00
Module 2: Essential Components of EU MDR 00:40:00
Module 3: Reporting Requirements and Identification 00:27:00
Module 4: Quality System in Medical Device Regulation 00:36:00

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