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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 length15-20 hours
Course fee
(per person)		from € 399
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ONLINE

YOU ARE HERE

€ 399​

Checkmark MDHQ  Average completion time​  15-20 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 29

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  6 months access to the course

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ONLINE LIFETIME

€ 499 ​

Checkmark MDHQ  Average completion time​  15-20 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 29

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  Lifetime access to the course and instructor

Learn more

IN-HOUSE TRAINING​

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Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Digital course companion
The personal digital course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.

Templates

Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.

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ONLINE
€ 399
15-20 hours
5.5 hours
29
6 months access
Buy now
ONLINE LIFETIME​
€ 499
15-20 hours
5.5 hours
29
Lifetime access
Buy now
IN-HOUSE TRAINING
Contact us
Tailored training to meet your company’s needs
Get a quote

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 online course is made up of pre-recorded videos, quizzes, and a final exam. There is also a downloadable course companion within the course. 

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).

medical device hq instructors - Pontus Gedda

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 and bite-sized learning

Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information. This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.

Checkmark MDHQ  Training effectiveness and record-keeping

Participants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness. Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability. 

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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
  • Identification within the supply chain
  • UDI
  • EUDAMED
  • 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
  • Final exam
  • 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.

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply). 

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.

Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form. 

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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.

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

"An excellent set of contents and flow of the fundamental information that can supercharge onboarding people into Medical Device Industry. The terms, concepts and requirements are simply and accurately explained and emphasize the right level of significance. Extremely happy with the experience!!"
Mayank Kakkar
Mayank KakkarManager, Stryker
"Pontus is a very knowledgeable trainer who presented the concepts in a clear and engaging way. I liked the pragmatic approach and found the course to be really helpful. The quizzes were fun and a useful part of the learning experience. Highly recommended!"
Ariadna Navarro
Ariadna NavarroAssociate Director Regulatory Affairs & Quality Assurance, AKRN Scientific Consulting
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Group purchase

If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.

If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.

It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.

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IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

I am taking the course Someone else will take the course

Oops, I actually wanted to buy seats for several people. Take me to the right place.

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