Essentials of European Medical Device Regulations (EU MDR) - 2017/745
Online USA
DURATION
1 up to 3 Hours
LANGUAGES
English
PACE
Full time, Part time
APPLICATION DEADLINE
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EARLIEST START DATE
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TUITION FEES
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STUDY FORMAT
Distance Learning
* free course
Introduction
This free online course explains the essentials of European Medical Device Regulations (EU MDR) - 2017/745. The course provides a way for learners to study the complex and detailed regulations, including the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors etc. This course will be of interest to all professionals working in the medical devices industry.
This Free Online Course Includes:
- 1.5-3 Hours of Learning
- CPD Accreditation
- Final Assessment
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Scholarships and Funding
As we are an online platform, we do not offer degrees or scholarships.
Curriculum
In this free online course Essentials of European Medical Device Regulations (EU MDR) - 2017/745 you will learn about the essentials of EU MDR that will introduce you to the updates and changes in the new regulations. The course covers old European directives on medical devices, active implants, and in-vitro diagnostics devices and how these will be replaced with new regulations. The course also covers the classification scheme of medical devices and the risk-based criteria for that.
The course begins by introducing you to the important improvements and significant changes in the EU MDR. The course then covers the economic operators in the sector and their increased responsibilities with this regulation. Next, it explains the Unique Device Identifier and reporting mechanism of data through EUDAMED.
This course will be of great interest to those working in Quality or Continuous Improvement departments in the medical devices industry, if you're considering working in the medical devices sector as a future career, or if you’re a medical devices professional seeking to learn about the European Regulations. So, start this free online course today and in just 3 hours you’ll be acquainted with the basics of the European Medical Device Regulations (EU MDR) - 2017/745.
Module 1
Introduction to European Regulations on Medical Devices
This module explains the existing relevant European directives for the medical devices sector in Europe and how these will be replaced with the new EU regulations. The module further elaborates on the important changes, improvements, and timelines of enforcement for the new regulations. The module also incorporates important terms from the EU MDR regarding the industry.
Module 2
Essential Components of the EU MDR
In this module, you will learn the technical documentation required for different classes of medical devices as per the new EU MDR, the change in archiving period, Post-market surveillance etc. The module then discusses the criteria for the classification of medical devices on elements of risk for the device. The module lists the 22 rules which govern the classification of the device and also shares some steps as a route to the market along with different Economic Operators' roles in the sector.
Module 3
Reporting Requirements and Identification
In this module, the reporting mechanism and identification of the medical devices as per the new EU MDR regulations are uncovered. The identification mechanism is based on the Unique device identifier (UDI) and the important elements within that. Furthermore, it also covers details about reporting requirements of EUDAMED.
Module 4
Course assessment
Program Outcome
What You Will Learn In This Free Course
- Explain the three directives on medical devices: IVDD, MDD & AIMDD.
- Discuss the transformation of old EU directives into new regulations and their relationships.
- Summarize the important improvements with the new EU MDR.
- Differentiate the different classes of medical devices and the criteria for classification.
- List the 22 rules of product classification for a medical device.
- Interpret the route to market for medical devices in Europe.
- Evaluate the roles of different economic operators in EU.
- Describe the applications and requirements of EU-UDI.
- Specify the requirements on EUDAMED in EU MDR.
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