CEU Credits: 0.1
Course Code: ELM-317
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
Previous Module
Module Introduction
Learning Objectives for this Module
Article 1 - Subject Matter and Scope
In Scope
Out of Scope
It Depends
Article 2 - Definitions
Marketed in the European Union
Medical Devices
Custom-Made Device
Active Device
Implantable Device
Invasive Device
Generic Device Group
Single-Use Device
Procedure Pack and System
Conformity Assessment and CE marking
Intended Purpose, Label and Instructions for Use (IFU)
Unique Device Identifier’ (‘UDI’)
Risk Management Definitions
Clinical Definitions
Economic Operators
Post-Market Surveillance and Market Surveillance
Refurbishing and Reprocessing
Commonly Understood Definitions
Overview
Article 3 - Amendment of Certain Definitions
Article 4 - Regulatory Status of Products
Conclusion
Final Assessment
Certification
