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Module 1: EU MDR 2017/745 Training - Chapter I - Scope and Definitions
Introduction
Overview
Previous Module
Module Introduction
Learning Objectives
Article 1 - Scope
Subject Matters and Scope
In Scope
Out of Scope
When in Doubt......
Article 2 - Definitions
Definitions
Market in the European Union
Medical Devices - Part 1
Medical Devices - Part 2
Custom Made Device
Active Device
Implantable Device
Invasive Device
Generic Device Group
Single Device Use
Procedure pack and System
Conformity Assessment and CE Mark
Intended Purpose, Label and Instructions for Use (IFU)
Unique Device Identifier (UDI)
RIsk Management Definition
Clinical Definitions
Economic Operators
Post-Market surveillance and Market surveillance
Refurbishing and Reprocessing
Commonly Understood Definitions
Articles 3 & 4
Article 3 - Amendment of certain definitions
Article 4 - Regulatory status of products
Summary
Training Summary
Final Assessment
Custom Made Device
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