EU Medical Device Regulations - 2017/745 | Free online course | Alison
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Essentials of European Medical Device Regulations (EU MDR) - 2017/745

In this free online course learn about the key aspects of the European Medical Device Regulations (EU MDR) - 2017/745.

Quality Control
Free Course
This free online course explains the essentials of European Medical Device Regulations (EU MDR) - 2017/745. The course provides a way for learners to study the complex and detailed regulations, including the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors etc. This course will be interest to all professionals working in the medical devices' industry.

Description

Modules

Outcome

Certification

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Description

In this free online course Essentials of European Medical Device Regulations (EU MDR) - 2017/745 you will learn about the essentials of EU MDR that will introduce you to the updates and changes in the new regulations. The course covers old European directives on medical devices, active implants, in-vitro diagnotics devices and how these will be replaced with new regulations. The course also covers the classification scheme of medical devices and the risk-based critera for that. 

The course begins by introducing you to the important improvements and significant changes in the EU MDR. The course then covers the economic operators in the sector and their increased responsiblities with this regulation. Next, it explains the Unique Device Identifier, and reporting mechanism of data through EUDAMED.

This course will be of great interest to those working in Quality or Continuous Improvement departments in a medical devices' industry, or if you're considering working in medical devices' sector as a future career, or if you’re a medical devices' professional seeking to learn about the European Regulations. So, start this free online course today and in just 3 hours you’ll be acquainted with the basics of the European Medical Device Regulations (EU MDR) - 2017/745.

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Learning Outcomes

After completing this course you will be able to:


  • Explain the three directives on medical devices: IVDD, MDD & AIMDD
  • Discuss the transformation of old EU directives into new regulations, and their relationships
  • Summarize the important improvements with the new EU MDR
  • Differentiate the different classes of medical devices and the criteria for classification
  • List the 22 rules of product classification for a medical device
  • Interpret the route to market for medical devices in Europe
  • Evaluate the roles of different economic operators in EU
  • Describe the applications and requirements of EU-UDI
  • Specify the requirements on EUDAMED in EU MDR

Certification

All Alison courses are free to enrol, study and complete. To successfully complete this Certificate course and become an Alison Graduate, you need to achieve 80% or higher in each course assessment. Once you have completed this Certificate course, you have the option to acquire an official Certificate, which is a great way to share your achievement with the world. Your Alison Certificate is:

Ideal for sharing with potential employers - include it in your CV, professional social media profiles and job applications
An indication of your commitment to continuously learn, upskill and achieve high results
An incentive for you to continue empowering yourself through lifelong learning

Alison offers 3 types of Certificates for completed Certificate courses:

Digital Certificate - a downloadable Certificate in PDF format, immediately available to you when you complete your purchase
Certificate - a physical version of your officially branded and security-marked Certificate, posted to you with FREE shipping
Framed Certificate - a physical version of your officially branded and security-marked Certificate in a stylish frame, posted to you with FREE shipping

All Certificates are available to purchase through the Alison Shop. For more information on purchasing Alison Certificates, please visit our FAQs. If you decide not to purchase your Alison Certificate, you can still demonstrate your achievement by sharing your Learner Record or Learner Achievement Verification, both of which are accessible from your Dashboard. For more details on our Certificate pricing, please visit our Pricing Page.

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