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.
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Course length
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15-20 hours
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Course fee
(per person)
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€ 399
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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 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
Become confident in the MDR
Become confident in the MDRThe 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 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
- 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
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.
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.
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.