- Introduction
-
Course goals
-
Welcome
-
What is a medical device according to MDR
-
Quiz - What is a medical device according to MDR
-
Introducing the stakeholders
-
Quiz - Introducing the stakeholders
- How to work with the MDR
-
The regulatory field
-
Quiz - The regulatory field
-
The ”whereas”, the articles and annexes - Part 1
-
The "whereas", the articles and annexes - Part 2
-
Distance sales and claims
-
Quiz - Distance sales and claims
- The definitions and codes of the MDR
-
The terms and definitions
-
Quiz - The terms and definitions
-
Classification of medical devices
-
Quiz - Classification of medical devices
-
Medical device codes - Part 1
-
Medical device codes - Part 2
-
Quiz - Medical device codes
-
Conformity definitions
-
Quiz - Conformity definitions
- Obligations of the manufacturer and other economic operators
-
General obligations of the manufacturer - Part 1
-
General obligations of the manufacturer - Part 2
-
Quiz - General obligations of the manufacturer
-
Person responsible for regulatory compliance
-
Quiz - Person responsible for regulatory compliance
-
Declaration of conformity and CE marking
-
Quiz - Declaration of conformity and CE marking
-
General safety and performance requirements - Part 1
-
General safety and performance requirements - Part 2
-
Quiz - General safety and performance requirements
-
Technical documentation
-
Quiz - Technical documentation
-
Other economic operators
-
Quiz - Other economic operators
-
Specific requirements for some devices - Part 1
-
Specific requirements for some devices - Part 2
-
Quiz - Specific requirements for some devices
- Identification and traceability of medical devices and economic operators
-
Identification within the supply chain
-
Quiz - Identification within the supply chain
-
UDI
-
Quiz - UDI
-
EUDAMED
-
Quiz - EUDAMED
- The involvement of a notified body in relation to the MDR
-
General requirements related to notified bodies
-
Quiz - General requirements related to notified bodies
-
Conformity assessment procedure
-
Quiz - Conformity assessment procedure
-
Notified body certificates
-
Quiz - Notified body certificates
- Clinical evaluation and PMCF
-
Clinical evaluation - Part 1
-
Clinical evaluation - Part 2
-
Quiz - Clinical evaluation
-
PMCF
-
Quiz - PMCF
- Post-market surveillance
-
Post-market surveillance (PMS) - Part 1
-
Post-market surveillance (PMS) - Part 2
-
Quiz - Post-market surveillance (PMS)
-
Vigilance
-
Quiz - Vigilance
- Final exam
-
Final exam - Medical Device Regulation
- Course evaluation
-
Course evaluation - Medical Device Regulation
Introduction to the Medical Device Regulation (EU) 2017/745
Learn about the European regulation for medical devices, MDR, and how to effectively implement its requirements during this self paced, interactive online course.
This online course focuses on the European regulation for medical devices, MDR. It covers an orientation of the Medical Devices Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
The course covers how to work with the MDR, obligations of the manufacturer and other economic operators, UDI & EUDAMED, clinical evaluation and PMCF, post-market surveillance, and vigilance.
Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate.
This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy and other Terms and Conditions at https://www.greenlight.guru/legal-info.
×