Certification of Medical Technology

Course guarantor:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

The course deals with the issue of placing medical devices on the market. The syllabus of the course is designed to cover the main steps in the process of CE marking and marketing.

Requirements:

Credit requirements:

The student is required to complete the assigned practical tasks in the exercises. A maximum of 70 points is possible in the seminars. A minimum of 40 points is required for credit. In addition, the student is required to write a final credit test for a minimum of 50% points.

Exam evaluation:

A student awarded credit is evaluated on the basis of an oral examination. A grading scale is used for the final assessment, which is in accordance with the ECTS grading scale.

Syllabus of lectures:

EU medical device certification system.

Preclinical testing of medical devices

Clinical evaluation of medical devices

Conformity assessment, cooperation with notified bodies

National (RZPRO) and European medical device databases (EUDAMED), vigilance system.

Specifics of medical devices with measuring function and sources of ionising radiation

Syllabus of tutorials:

Work with legislative documents (EU Regulation 2017/745, MEDDEV)

Biocompatibility, electrical safety testing

Clinical evaluation 1 - clinical trials

Clinical evaluation 2 - equivalence, literature search

Technical documentation for conformity assessment

Adverse event reporting and management systems (vigilance system)

Study Objective:

Study materials:

Fundamentals of EU Regulatory Affairs. 8th. Regulatory Affairs Professionals Society (RAPS), 2017. ISBN 978- 1947493032.

Note:

The materials used in teaching are stored in MS Teams. For access contact Ing. Vojtěch Kamenský - kamenvoj@fbmi.cvut.cz

Time-table for winter semester 2025/2026:

Time-table is not available yet

Time-table for summer semester 2025/2026:

Time-table is not available yet

The course is a part of the following study plans:

• Biomedical Engineering (compulsory course)