Essentials of European Medical Device Regulations Course (EU MDR) - 2017/745 (Free Online Course With Certificate)

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

Alison Certificates

All Alison courses are free to enrol study and complete. To successfully complete this Diploma course and become an Alison Graduate, you need to achieve 80% or higher in each course assessment. Once you have completed this Diploma course, you have the option to acquire an official Diploma, which is a great way to share your achievement with the world.

Your Alison Diploma is:

• Ideal for sharing with potential employers
• Include it in your CV, professional social media profiles and job applications.
• An indication of your commitment to continuously learn, upskill & achieve high results.
• An incentive for you to continue empowering yourself through lifelong learning.

Alison offers 3 types of Diplomas for completed Diploma courses:

• Digital Diploma: a downloadable Diploma in PDF format immediately available to you when you complete your purchase.
• Diploma: a physical version of your officially branded and security-marked Diploma, posted to you with FREE shipping.
• Framed Diploma: a physical version of your officially branded and security-marked Diploma in a stylish frame, posted to you with FREE shipping.

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

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.

Complete This CPD Accredited Course & Get Your Certificate!

Certify Your Skills

A CPD-accredited Alison Diploma/Certificate certifies the skills you’ve learned.

Stand Out From The Crowd

Add your Alison Certification to your resume and stay ahead of the competition.

Advance in Your Career

Share your Alison Certification with potential employers to show off your skills and capabilities.

Medical Director

By virtue of its goal to heal humankind, the medical profession has guidance and leadership embedded into it.

Medical Biller

Attention to detail is one of the critical skills that healthcare professionals share in common.

Health Information Technician

The healthcare sector is home to many careers, from nurses and surgeons to therapists, offering several essential services for our well-being. An often-overlooked category of experts in this vast field is that of Health Information Technicians.

Medical Secretary

Their knack for taking meticulous care of multiple administrative and interpersonal tasks calmly and efficiently makes Medical Secretaries a vital cog in the healthcare industry - one that enables the effective treatment of patients.