The Important Regulatory Changes in the European Market

Introduction to Regulatory Change
The enforcement of the two new regulations is in-place and well planned. However due to COVID-19, EU MDR was supposed to be enforced on 25 May 2020. Its enforcement is extended for an year to May 2021. Now, after the enforcement we might have only two regulations, instead of three directives. But this course is only focused on MDR 2017/745.

Module 1: Introduction to European Regulations on Medical Devices

Module 1: Introduction to European Regulations on Medical Devices

Introduction to European Regulation on Medical Devices - Learning Outcomes

The Three European Directives on Medical Devices

The Important Regulatory Changes in the European Market

Terms and Definitions

Publication of EU MDR and Important Points

Introduction to European Regulation on Medical Devices - Lesson Summary

Module 2: Essential Components of the EU MDR

Essential Components of EU MDR - Learning Outcomes

Technical Documentation & Post-market Surveillance

Classification of Devices and Route to Market

Economic Operations & Clinical Evaluation

Essential Components of EU MDR - Lesson Summary

Module 3: Reporting Requirements and Identification

Reporting Requirements and Identification - Learning Outcomes

Unique Device Identifier (UDI)

European Database on Medical Devices (EUDAMED)

Reporting Requirements and Identification - Lesson Summary

Course assessment

European Medical Device Regulations - Course assessment

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