In-Depth MDR Online eLearning Course
Medical Device Regulation (MDR) Foundation Course (EU) 2017/745
Available September 1st
with tutor support when you need it
No additional fees
No membership or assessment fees
We have partnered with Comply Guru, an expert leader in online training to make our MDR course available as an eLearning course.
This fully online EU MDR training course is the most comprehensive, self-paced course available on the EU Medical Device Regulation (MDR) and offers both an industry and notified body insight with practical examples throughout.
This course provides you with full flexibility to learn at your own pace and in your own time.
In this course, you'll cover 9 units:
Unit 1: Introduction to the EU MDR
▪ History of the EU-MDR
▪ Purpose of the EU-MDR
▪ Structure of EU-MDR
▪ Key Terminology
▪ Key EU-MDR changes
▪ EU-MDR Timelines for transition
Unit 2: Medical devices covered by EU-MDR
▪ What is a device?
▪ Devices in scope
▪ Devices out of scope
▪ Non-Medical devices
Unit 3: Placing a Device on the Market
▪ Overview of Chapter II
▪ Articles 5-9
▪ Economic Operator & PRRC Responsibilities
▪ Articles 16-24
Unit 4: Device Classification
▪ Overview of Annex VIII
▪ Class Types
▪ Classification Rules
Unit 5: Routes To Conformity
▪ Overview of Conformity Annexes
▪ Annex IX
▪ Annex X
▪ Annex XI
▪ Custom Made Devices
▪ Notified Body Articles & Annexes
Unit 6: GSPR & Risk Management
▪ Overview of Annex I
▪ Chapter I General Requirements
▪ Risk Management
▪ Chapter III Device Information
You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher.
Successful completion will entitle you to receive a certificate of completion.
Working knowledge of medical device quality management systems (QMS) and risk management is recommended prior to completing this course.
If you don't have this, you can begin with the 2-hour MDR Overview, which has no entry requirements.
This course is most suited to individuals who are responsible for or involved with the implementation or maintenance of a medical device QMS, Including but not limited to:
- QA Professionals
- Quality Engineers
- Research & Design Engineers
- Internal Auditors
- Quality Managers
- Regulatory Professionals
- Manufacturing Engineers
Unit 7: Clinical Evaluation
▪ Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV
Unit 8: Technical Documentation
▪ Overview of Annex II & III
▪ Contents of Technical Documentation
▪ Device Description
▪ Verification & Validation
Unit 9: Post Market Surveillance & Vigilance
▪ Overview of PMS Articles 83-86
▪ Overview of Vigilance Articles 87-89