Medical Devices – Regulation 2017/745 – Basics
About the course
Target group
Healthcare professionals
Key words
Course introduction
This course emphasizes on the importance of the Regulation 2017/745 aiming to give to students basic understanding on this particular document regulating the Medical Devices. It will help you to gain a basic knowledge on the subject and will facilitate the application of the regulation in your context.
Details to know
Downloadable certificate
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Assessment
2 Quizzes
Learning outcomes
Module 1 & 2:
- Competence
- Is able to apply the fundamental principles of EU Regulation 2017/745 to ensure compliance in medical device usage and clinical investigation.
- Knowledge
- Knows the importance, scope, and key provisions of EU Regulation 2017/745 concerning medical devices.
- Can identify key components of the regulation, including its application to medical devices.
- Skills
- Identifies the classification of medical devices under the regulation.
- Explains the compliance requirements for medical device approval and market access in the EU.
- Recognises the role of clinical investigation in ensuring medical device safety and effectiveness.
Basics on the Regulation and Compliance
Lessons
Introduction 1. Basics on the Regulation and Compliance ReferencesInformation and Clinical Investigation
Lessons
Introduction 1. Information and Clinical Investigation References Course Evaluation
Co-funded by the Erasmus+ programme of the European Union under Grant Agreement number 101056563.
Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EACEA. Neither the European Union nor the granting authority can be held responsible for them.