Classification of Devices and Route to Market

All devices will be classified into one of four risk classes.

On the Medical Device Regulation there are 4 classes:

• Class I
• Class IIA
• Class IIB
• Class III

Module 1: Essential Components of the EU MDR

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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