INTRODUCTION TO THE MEDICAL DEVICE REGULATION (EU) 2017/745

ONLINE COURSE

Learn about the European regulation for medical devices, MDR, and how to effectively implement its requirements during this self paced, interactive online course.

Online course
Course length
15-20 hours
Course fee (per person)
€ 399
Purchase the course access for single user:
Purchase the course access for a group of users:

Course description

This online course focuses on the European regulation for medical devices, the MDR. It covers an orientation of the Medical Device Regulation according to (EU) 2017/745 as well as related guidance, like MDCG, and how to apply to a notified body for conformity assessment.

Topics covered include: how to work with the MDR, obligations of the manufacturer and other economic operators, UDI & EUDAMED, clinical evaluation and PMCF, post-market surveillance and vigilance.

It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.

The Medical Device Regulation course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.

Pontus Gedda - Medical Device HQ instructor

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.

Benefits for you

Checkmark MDHQ Become confident in the MDR

The goal is that upon completion of this course, you should understand the overall structure and requirements of the MDR and where to find the answers to any stakeholders’ questions. You should also be confident in communicating with the regulators and other experts.

Checkmark MDHQ Self paced learning

You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.

Checkmark MDHQ Course certificates to prove to regulatory bodies you know your stuff

Auditors will look for evidence that you are competent in the MDR. You will have a nice-looking course certificate to bring up if you will get the question during an audit. Avoid the discussion with the auditor if you know the basis of the MDR or not.

Course programme

  • Welcome
  • What you need to know
  • Set your course goal completion date
  • Pre-course assessment quiz
  • What is a medical device according to the MDR
  • Introducing the stakeholders
  • The regulatory field
  • The ”whereas”, the articles and annexes – Part 1
  • The ”whereas”, the articles and annexes – Part 2
  • Distance sales and claims
  • The terms and definitions
  • Classification of medical devices
  • Medical device codes – Part 1
  • Medical device codes – Part 2
  • Conformity definitions
  • General obligations of the manufacturers Part 1
  • General obligations of the manufacturers Part 2
  • Person responsible for regulatory compliance
  • Declaration of conformity and CE marking
  • General safety and performance requirements – Part 1
  • General safety and performance requirements – Part 2
  • Technical documentation
  • Other economic operators
  • General requirements for the notified bodies
  • Conformity assessment procedures
  • Notified body certificates
  • Clinical evaluation – Part 1
  • Clinical evaluation – Part 2
  • PMCF
  • Post-market surveillance (PMS) – Part 1
  • Post-market surveillance (PMS) – Part 2
  • Vigilance
  • Course evaluation

NOTE – The course program structure is subject to change

Frequently asked questions

The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
All in all, the average time to complete the course is 15-20 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.
You will have access to the course for six months.
You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.
There is no certification or accreditation for MDR knowledge, however the instructor has worked for a notified body for many years and has participated in NB-MED and expert groups which is probably the highest qualification you can have in this area.
There are no pre-requisites for this course.

Testimonials

Group purchase

You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.

For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.

With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

Still haven’t decided?
Get in touch with us and get more information:

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