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Home » EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions

EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions (ELM-317)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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Biopharma Institute LogoTraining Program: EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThere are only four articles in this chapter. Articles 3 and 4 are comparatively short so naturally we shall spend the bulk of the time in this module examining Articles 1 and 2. In this module, we will cover Article 1 - the Subject Matter and Scope, which sets out what this regulation applies to as well as what this regulation does NOT apply to. We shall also examine where a decision is required to determine which set of regulations (other than EU MDR 2017/745) a product is governed by.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions course is included in the following Professional Certification Programs:

EU Medical Device Regulation (EU MDR) for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Previous Module
Module Introduction
Learning Objectives for this Module

Article 1
Article 1 - Subject Matter and Scope
In Scope
Out of Scope
It Depends

Article 2
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

Articles 3 and 4
Article 3 - Amendment of Certain Definitions
Article 4 - Regulatory Status of Products


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).

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