INTRODUCTION TO MDR, Medical Device Regulation (EU) 2017/745ONLINE COURSE - COMING SOON
Learn how to understand the European regulation for medical devices during this self paced, interactive online course.
|Course length||15-20 hours|
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We are currently looking for people to validate this course in exchange for free course enrolment.
Please apply to be a validator by clicking on the button which will take you to an application form.
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 guidance’s, like MDCG, and how to apply to a notified body for conformity assessment.
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.
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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.
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.
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 MDR
- Introducing the stakeholders
Lesson 2. The regulatory background of MDR
- The regulatory field
- What are the main changes compared to MDD
Lesson 3. Introduction to MDR, its structure and content
- The ”Whereas” and Articles (and chapters) and Annexes
- Harmonized standards, common specifications and guidance’s
Lesson 4. The terms and definitions of the MDR
- Calling things by their right names
- Medical device definitions and codes
- Conformity definitions
Lesson 5. Obligation of the manufacturer and other economic operators
- General obligations of the manufacturers Part 1
- General obligations of the manufacturers Part 2
- Annex I GSPR
- Other economic operators
- Person responsible for regulatory compliance
- Specific requirements for some devices
- Declaration of conformity and CE marking
Lesson 6. Identification and traceabillity of medical devices and economic operators
- Identification within the supply chain
- EUDAMED Part 1
- EUDAMED Part 2
- UDI Part 1
- UDI Part 2
- Classification of devices
- Annex VIII classification rules
Lesson 7. The involvement of a notified body in relation to MDR
- General requirements for notified bodies
- Conformity assessment procedures
- Annex IX QMS (Chapter 1)
- Annex IX Technical documentation (Chapter II)
- Annex X Type examination
- Annex XI Product conformity verification – Part A
- Annex XI Product conformity verification – Part B
- Application to a notified body
- What will the notified body do?
- Technical documentation assessments and audits
- Annex II Technical documentation
- The CERTIFICATE
0 Base Course
Lesson 8. Clinical evaluation and clinical investigations
- Clinical evaluation
- Annex XIV Clinical evaluation and PMCF
- Clinical investigations
- Annex XV Clinical investigations
Lesson 9. Post market surveillance
- Post market surveillance (PMS)
- Annex III Technical documentation on PMS
- Post market clinical follow up and report (PMCF and PSUR)
- Market surveillance activities
Lesson 10. Special requirements
- 120 and 123: MDD transition
- Specific requirements
- Annex XIII Custom made device
- Annex XVI Products with no medical purpose
Lesson 11. Summing up the Annexes
- Annex I GSPR
- Annex II Technical Documentation
- Annex III Technical Documentation on PMS
- Annex IV Declaration of Conformity
- Annex V CE Marking
- Annex VI EUDAMED and Data (Part A)
- Annex VI UDI Core Data Elements (Part B)
- Annex VI The UDI System (Part C)
- Annex VII Notified Bodies
- Annex VIII Classification Rules
- Annex IX QMS (Chapter I)
- Annex IX Technical Documentation (Chapter II)
- Annex X Type Examination
- Annex XI Product Conformity Verification Part A
- Annex XI Product Conformity Verification Part B
- Annex XII Certificates issued by a Notified Body
- Annex XIII Custom Made Device
- Annex XIV Clinical Evaluation and PMCF
- Annex XV Clinical Investigations
- Annex XVI Products with No Medical Purpose
- Annex XVI Correlation Table
Lesson 12. Summary
- Summary of the MDR
Lesson 13. Final exam
- Final exam
Lesson 14. 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.