Comply Guru offer both a European Medical Device Regulation (EU MDR 2017/745) Essentials Course and/or a European In Vitro Diagnostic Regulation (EU IVDR 2017/746) Essentials Course for organizations looking for a concise, high-level introduction for their staff.

Our eLearning courses are a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

These essentials courses are exclusively offered to in-company groups (min. order required).

Why Comply Guru?

  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
Why Choose Comply Guru?
Learn Anywhere, Anytime
Course Access for 6 Months
Self-Paced Learning Experience
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+
Course Snapshot
Accreditation
Comply Guru
Duration
2hrs
Available Format
eLearning
Language (s)
English
Price
In-Company Groups
Learner Rating
★★★★★ 244 Reviews
Why Choose Comply Guru?
Learn Anywhere, Anytime
Course Access for 6 Months
Self-Paced Learning Experience
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+

Course Overview

EU Regulations Essentials

Learning Objectives

On completion of the MDR essentials course, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose, and structure of the EU MDR
  2. Describe the key changes to the EU MDR from the MDD
  3. Identify the different roles and responsibilities associated with the EU MDR
  4. Outline the requirements for placing a medical device on the market

On completion of the IVDR essentials course, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose, and structure of the EU IVDR
  2. Describe the key changes to the EU IVDR from the IVDD
  3. Explain what an IVD medical device is
  4. Describe the types of IVD devices that are covered by the regulation
  5. Outline some other key aspects of the new EU IVDR
Who Should Attend

These courses are for organizations who wish to provide their staff with a short, general overview of either the EU MDR and/or EU IVDR. There is a minimum order requirement for this training.

Please note, these are separate courses per EU regulation (not combined).

Course Certificate

Successful completion will entitle each Learner to receive a digital Certificate of Completion.

How Will You Be Assessed

In order to successfully complete either course, each Learner will need to:

  • Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Who Choose Our eLearning?

Learn about how our eLearning methodology is leading the industry for innovation through online learning

 
Why Choose eLearning

What Our Learners Are Saying

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Frequently Asked Questions

Unfortunately not. The Essentials courses are only available for groups of 5 or more. If you would like a quote, please complete a Request Quote form and a member of our team will contact you to discuss this further.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 30 days (1 month). Access is available 24/7 for the full 30-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Once you have completed the final assessment, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020