INTRODUCTION TO THE MEDICAL DEVICE REGULATION (EU) 2017/745ONLINE COURSE
Learn how to understand the European regulation for medical devices during this self paced, interactive online course.
|Course length||15-20 hours|
Purchase the course access for single user:
This online course focuses on the European regulation for medical devices, MDR. It covers an orientation of the Medical Devices Regulation according to (EU) 2017/745 as well as related guidances, 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 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.
Benefits for you
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.
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.
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 MDR or not.
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 thru 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.
0 Base Course
Lesson 1. Introduction
- 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
Lesson 2. How to work with the MDR
- The regulatory field
- The ”whereas”, the articles and annexes – Part 1
- The ”whereas”, the articles and annexes – Part 2
- Distance sales and claims
Lesson 3. The definitions and codes of the MDR
- The terms and definitions
- Classification of medical devices
- Medical device codes – Part 1
- Medical device codes – Part 2
- Conformity definitions
Lesson 4. Obligations of the manufacturer and other economic operators
- 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
Lesson 5. Identification and traceabillity of medical devices and economic operators
- Identification within the supply chain
0 Base Course
Lesson 6. The involvement of a notified body in relation to the MDR
- General requirements for the notified bodies
- Conformity assessment procedures
- Notified body certificates
Lesson 7. Clinical evaluation and PMCF
- Clinical evaluation – Part 1
- Clinical evaluation – Part 2
Lesson 8. Post-market surveillance
- Post-market surveillance (PMS) – Part 1
- Post-market surveillance (PMS) – Part 2
Lesson 9. Final exam
- Final exam
Lesson 10. Course evaluation
- Course evaluation
NOTE – The course program structure is subject to change
Frequently asked questions
Is the course a live webinar?
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.
How long does it take to complete 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.
How long will I have access to the course?
You will have access to the course for six months.
What if I lose internet connection during the final exam?
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.
Can I fail the final exam?
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!
Where can I find my course certificate?
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.
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on firstname.lastname@example.org if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer and you will incur an invoicing fee.
Can I view the course on a mobile device?
Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
Do you offer volume discounts?
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.
Can a colleague and I take the course at the same time?
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.
Is the instructor accredited or certified to give this training?
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.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
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:
You will be registered and automatically logged in after the checkout
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?