Online Comprehensive EU Medical Device Regulation/MDR 2017/745 Practitioner Course | CQI, IRCA & Exemplar Global Certified

(38 Reviews, Click to view)


Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this CQI, IRCA & Exemplar Global certified Comprehensive EU Medical Device Regulation (MDR) 2017/745 Practitioner Course – it is the first and most comprehensive online & self-paced course to be released in the world!

Meddev Solutions Logo-Large

Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.

Our online, self-paced CQI, IRCA & Exemplar Global certified course can take you through the regulation, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for. This course will focus on the overview & application – it isn’t just a simple ‘read and understand,’ it is a practical ‘how to’ guide, which you can actually use immediately.

Course Snapshot

  • Course Duration:

    20 Hours
  • Continuing Education Units:

  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner
    CQI, IRCA & Exemplar Global Certified Course
  • Delivery Options & Discounts

    • Online & Self-Paced Only
    • Discounts Available for 10+ Licenses
  • Price

  • Fee Includes

    • Course Access for 90 Days
    • Virtual Instructor Assistance – Phone & Email Support
A video about Comply Guru's online training library for compliance and certification

New! Online Comprehensive EU MDR Practitioner Course!

In this video, Eoin provides an overview of our new Comprehensive EU Medical Device Regulation (MDR) Practitioner Course – Check it out!

This certified course is online, self-paced & available 24/7/365
This certified course is online, self-paced & available 24/7/365

This certified course is online, self-paced & available 24/7/365

This course is certified by CQI, IRCA & Exemplar Global!

Start DateLocationCostDurationActionsVolume License


Includes Access Logo

The MDR Guidebook from Meddev - Get 25% Off

For anyone involved in ensuring compliance with the EU MDR, this Guidebook is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again. It contains a number of useful tools and tables to guide you through the MDR & with each online course purchase, you receive a 25% off discount code!

  • Module 0: Course Introduction (Online & Self-Paced)

    • Accessibility
    • Player Features
    • Course Objectives
    • Course Description
    • Module Structure
    • Assessment
    • Meet Our Partner and Expert
    • Learner Support
    • Available Resources

  • Module 1: Introduction to the EU-MDR (Online & Self-Paced)

    • History of the EU-MDR
    • Purpose of the EU-MDR
    • Structure of EU-MDR
    • Key Terminology
    • Key EU-MDR changes
    • EU-MDR Timelines for transition

  • Module 2: Medical devices covered by EU-MDR (Online & Self-Paced)

    • What is a device?
    • Devices in scope
    • Devices out of scope
    • Non-Medical devices

  • Module 3: Placing a Device on the Market (Online & Self-Paced)

    • Overview of Chapter II
    • Articles 5-9
    • Economic Operator & PRRC Responsibilities
    • Articles 16-24

  • Module 4: Device Classification (Online & Self-Paced)

    • Overview of Annex VIII
    • Class Types
    • Classification Rules

  • Module 5: Routes To Conformity (Online & Self-Paced)

    • Overview of Conformity Annexes
    • Annex IX
    • Annex X
    • Annex XI
    • Custom Made Devices
    • Notified Body Articles & Annexes

  • Module 6: GSPR & Risk Management (Online & Self-Paced)

    • Overview of Annex I
    • Chapter I General Requirements
    • Risk Management (ISO 14971, Chapter II Design & Manufacture
    • Chapter III Device Information

  • Module 7: Clinical Evaluation (Online & Self-Paced)

    • Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV

  • Module 8: Post Market Surveillance & Vigilance (Online & Self-Paced)

    • Overview of PMS Articles 83-86
    • Overview of Vigilance Articles 87-89

  • Module 9: Technical Documentation, UDI and Eudamed (Online & Self-Paced)

    • Annex II and Annex III Technical documentation
    • Unique Device Identification (Annex VI)
    • UDI Timelines
    • Overview of Eudamed

Exemplar Global

This course is certified by Exemplar Global under the RTP Program, plus this course is certified by CQI & IRCA (No. 2378). This course is offered with dual certification from both CQI & IRCA as well as Exemplar Global.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in three final assessments. This course is available in three parts, each with its own assessment. Successful completion will entitle each Learner to receive a certificate of completion.


  • Great course and great content. Could learn at your own pace and the sections were broken down into very manageable modules. Will definitely be recommending to my colleagues

    Sarah Gallagher | February 22, 2021

  • The course was a good intro to MDR

    Jade Willows | February 22, 2021

  • This course was an excellent overview of the EU-MDR a good introduction either for someone just starting to work in depth with the regulation or for someone only wanting an overview. The self pace format worked very well for me.

    Cyndy Adams | February 19, 2021

  • The overall experience was absolutely positive.

    Anonymous | February 15, 2021

  • The EU MDR training was very informative and rewarding. Three assessments with 30 Qs each provide a challenging task for the user. I now feel more confident on my knowledge of the new European Medical Device Regulation and the expectation from Medical Device companies.

    Lee Kilbridge | February 12, 2021

  • I very much enjoyed the training. I had taken a 1-day course previously and felt it did not provided enough detail. This course was excellent at providing the level of details I wanted to knwo regarding the new MDR. Also the fact that it is designed utilizing various training techniques videos visuals. readings etc. make the training refreshing and interesting.

    Noemi Rivera | February 10, 2021

  • the course is so fruitful and interesting

    Mahmoud Desoki | February 6, 2021

  • Course was very well planned and well delivered. Resources attached with the course also excellent. Overall very positive experience and would recommend.

    Oyinkan Donaldson | February 3, 2021

  • This training was actually fun. Nice variety in the presentation.

    Christine Vergely | January 27, 2021

  • it was fine

    Sheila Hunter | January 26, 2021

  • I am really happy with the servcie of the Comply Guru. The course itself is very well structured and explained in a way that anyone can attend it.I will really recommend it to RA Specialists.

    Muhammad Zubair | January 22, 2021

  • Good and challenging course

    Dawn Matic | January 15, 2021

  • Really nice training with clear information and additional resources

    Marianne Engels | January 12, 2021

  • I was happy with the course the time taken was a lot shorter than predicted which was useful.

    Claire Abrahams | January 11, 2021

  • Course provided a good foundation of the topic. Division of course in to three sections meant that one was less likely to get bogged down

    Charlotte Dugdale | January 8, 2021

  • As said above this was great experience I think your training was well structured and useful.Well done.

    Thomas Colson | January 7, 2021

  • Well done Modules were done great and the on demand experience was excellent.

    Amy Jones | January 4, 2021

  • Courses were helpful and practical.

    Randy Evers | December 29, 2020

  • Great experience. I enjoyed being able to train at my one pace and timing.

    Chuck Setzer | December 16, 2020

  • Engaging interesting and can be done on your schedule

    Ravi Kommineni | December 16, 2020

  • Good course material and presentation to learn about the EU MDR

    | December 14, 2020

  • I feel quite confident to handle the RA part of my job after this course. I came in with 3/10 knowledge score and would place myself at 7/10 after the course

    Prasanna Venkatesh Rangadurai | November 24, 2020

  • Comply Guru offer interactive learning which was very helpful in training up on the EU MDR. I would definitely recommend their services to a coworker.

    Aine Dooley | November 24, 2020

  • Good quality material supplied. Clear instructions and information given. Very helpful and fast reacting team.

    Kateryna Anisimova | November 23, 2020

  • Experience was good. Exams were difficult

    Olive Gunning | November 23, 2020

  • The material is covered in the course is beneficial to my job. There was a good balance between presentations and exercises. The course was a good learning experience.

    Maryna Zhukava | November 20, 2020

  • I found this course to be very relevant to the needs of practitioners who need to know more about EU MDR. This course maintains the style pacing and delivery of the General Overview course. Again this more in-depth course is well-paced and has well thought out knowledge checks learner interactions and additional supplementary videos by the trainer. This is a recommended course for someone that needs to go further into EU MDR.

    Tom Healy | November 19, 2020

  • The course was great It was wonderful that is was on demand and self-paced Would consider more training through Comply Guru.

    Sarah Evans | November 18, 2020

  • This course was very informative and helped me to have a better understanding of the EU MDR regulations.

    Stephana Biggins | November 16, 2020

  • I found the course itself to be very comprehensive and tutor was very knowledgeable on EU MDR. I like the onlineself paced training as it would be difficult for me to set aside 2.5 days for traditional classroom based training.I have no issue with content or format of this training.

    Angela Kelly | November 12, 2020

  • Thoroughly enjoyed the EU MDR in-depth course lots of learning for it. Speaker in videos very clear and website user-friendly.

    Fiona Kirwan | November 10, 2020

  • I was able to learn and comprehend the information from the course. I had no training on this information prior but did well during the examinations after each course section.

    Danielle Wilson | November 3, 2020

  • I just completed the EU Medical Device Regulation In-Depth Foundation Course. It was my first experience doing an online self-paced course. And I must say I have already enquired about doing more courses with Comply Guru as I am totally pleased with such a delivery method The Comply Guru Team themselves was very helpful and responsive throughout the course duration and addressed all questions I had. If you are looking for a course that would help you to gain the knowledge you need while making it an interactive experience then I recommend you try this one

    Iryna Barouskaya | November 1, 2020

  • The delivery and content of the EU Medical Device Regulation MDR 2017745 In-Depth Foundation Course was excellent. The balance of video to theory was perfect.The course covers enough detail to provide anyone new to the Medical Device regulations with a good understanding of the requirements with good practical examples

    Cormac Mac Liathain | October 29, 2020

  • No additional comments

    Kim Tompkins | October 25, 2020

  • Great experience. Reasonably priced self-paced course. Knowledge checks were very helpful in maintaining the knowledge.

    Matthew Fortson | October 16, 2020

  • This course is a great overview of the MDR for anyone working in the Medical Device industry that wants a detailed introduction to the MDR requirements.

    Elaine Lynch | October 14, 2020

  • A very positive experience, the design of each program is on the money! The content is of a high standard and has the right match of clarity and detail. The delivery of the content is very smooth and professional and conveys all that is necessary for the participant to gather the information that is necessary to meet the objectives. As a quality/regulatory professional with over 20 years experience and a MSc in Medical Technology Regulator Affairs, I fully endorse Comply Guru as a preferred supplier of Quality/Regulatory training.

    Brian O'Connell | September 28, 2020

This course would be targeted at:

  • Quality assurance professionals
  • Quality Engineers
  • Research and design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals

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

  • Complete the online, self-paced course modules and obtain 70% or higher in three final assessments (MCQ-based Assessments)
  • This course is available in three parts, each with its own final assessment at the end of each part. A Learner may only progress to the next part upon successful completion of the previous part as the learning is progression based (sequential).
  • Instructor Image
    Rod Beuzeval

    Rod has worked in Pharmaceutical and Medical Device sectors for over 19 years and holds a degree in engineering.

    Read More

E-Learning System Requirements

The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or 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.

Recommended Operating Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

Internet Speed

We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

Recommended Internet Browsers

  • Google Chrome 32 bit version 50 or later
  • Safari 10 or later
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:
  • Cookies
  • Pop-ups (in both Internet Browser and security software)
  • JavaScript
  • Plugins
  • Latest Version of Adobe Flash Player
  • Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 99%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 95%

    Would Recommend Online or Blended Training over Classroom Training

Custom Course Development

We can combine leading industry subject matter experts with an experienced eLearning team to help your organization with its compliance training needs.

Want to learn more? Get in touch.

Would you like to know more about our service? We have a dedicated sales team who would be happy to answer any questions that you may have.

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