Code | Completion | Credits | Range | Language |
---|---|---|---|---|
F7ADIMDR | ZK | 20P+8C | English |
The course introduces the new medical device regulation that came in force on April 2017.
The subjects are concluded by an oral examination preceded by a written preparation (written test and ECG quiz). The student must elaborate a paper on a given topic together with the exam in case of the controlled self-study.
The study is performed in the form of controlled self-study with regular consultations and obligatory participation in laboratory exercises.
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 exercises:
1. Prepare a summary paper for a given topic (4 hours)
2. Sample of written test questions (4 hours)
The course introduces the new medical device regulation that came in force on April 2017.
Required:
[1] POMMELIN, Petri. The Survival Guide to EU Medical Device Regulations. Books on Demand, 2017. ISBN 978-9515681201.
Recommended:
[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/.