Medical Device Regulation (MDR)

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Code Completion Credits Range Language
F7DIMDR ZK 20P+8C English
Garant předmětu:
Roger Abächerli
Roger Abächerli
Roger Abächerli
Department of Biomedical Technology

The course introduces the new medical device regulation that came in force on April 2017.


In the case of foreign lecturers, there will be a weeklong block of intensive contact education for the number of students at least five. If the number of students is less than five, the course will be self-study with consultations using VoIP (e.g. Skype) and a contact 1-or 2-day seminar. The contact seminar will take place at the FBMI or at the home institution of a foreign lecturer. The subjects are concluded by an oral examination. The student must elaborate a paper on a given topic together with the exam in case of the controlled self-study.

Two laboratory exercises are required for admission to the exam (attested by a protocol signed by the student, the tutor and the supervisor of the course).

The protocols will be archived in the Department for Doctoral Studies.

Syllabus of lectures:

Syllabus of lectures:

1. Introduction to MDR

2. Transition period. Conformity.

3. Classification. Scrutiny

4. Common Specifications

5. Non-medical Devices and MDR

6. Requirements on different players. Responsible person.

7. New fundamental requirements

8. Technical documentation

9. Clinical evidence

10. Post-market Surveillance, Eudamed / UDI

Syllabus of tutorials:

Syllabus of exercises:

1. Prepare a summary paper for a given topic (4 hours)

2. Sample of written test questions (4 hours)

Study Objective:

The course introduces the new medical device regulation that came in force on April 2017.

Study materials:


[1] POMMELIN, Petri. The Survival Guide to EU Medical Device Regulations. Books on Demand, 2017. ISBN 978-9515681201.


[1] O'BRIEN, Des. Medical Device Regulations Roadmap: A Beginners Guide. CreateSpace Independent Publishing Platform, 2017. ISBN 978-1978202955.

[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. [Online]. Available from: http://eur-lex.europa.eu/.

Time-table for winter semester 2023/2024:
Time-table is not available yet
Time-table for summer semester 2023/2024:
Time-table is not available yet
The course is a part of the following study plans:
Data valid to 2024-04-17
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