Medical Device Regulation (MDR)

Course guarantor:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

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

Requirements:

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:

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/.

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans: