Legislation in Healthcare and Clinical Evaluation

Course guarantor:

Ondřej Gajdoš

Lecturer:

Ondřej Gajdoš, Vojtěch Kamenský, Peter Kneppo

Tutor:

Ondřej Gajdoš, Vojtěch Kamenský

Supervisor:

Department of Biomedical Technology

Synopsis:

Requirements:

Mandatory participation in 80% of the seminars. Credit test (written for min. 50%).

Written examination test for 50 points, the student must write the test for at least 50% of the points to be admitted to the oral examination (possibility of earning up to 50 points).

The overall assessment is a combination of points for the written test and the oral examination. In total, the student has the opportunity to obtain 100 points, a minimum of 50 points is required to complete the course. Evaluation according to the ECTS scale.

Syllabus of lectures:

Fundamentals of law. Types of legal norms. Legal system (types of legislative regulations in the Czech Republic and the EU). Legislative process in the Czech Republic and the EU.

Regulation of free movement and goods in the EU. Harmonization at EU level. Technical standardization system.

MDR 2017/745 on medical devices. Placing a medical device on the market.

MDR 2017/745 conformity assessment procedures, notified bodies

MDR 2017/745 - Technical documentation and description of individual parts. Pre-clinical and clinical evaluation.

Legislation on the use of medical devices (medical devices law) specifics of medical devices with sources of ionizing radiation („atomic law“).

Legislative framework of measuring devices. Metrological system in the Czech Republic. Legal metrology in healthcare.

Law on Public Procurement.

Healthcare as part of the public sector and their legislative framework (selected parts of the Act on Health Services, their implementing regulations and the Act on Medical and Non-Medical Health Professions).

Healthcare as part of the public sector and their legislative framework (health insurance legislation).

System and legislative regulation of quality assessment. Legislation related to the evaluation of the quality and safety of health services according to the Act on Health Services.

Legislative regulation of the protection of industrial property.

Syllabus of tutorials:

Search in legal regulations. Analysis of selected legal regulations (structure, hypothesis-disposition-sanctions, conditions for implementation of the legal regulation).

Technical standards in the healthcare sector search in technical standards, analysis of safety requirements for products in connection with proof of conformity.

Classification of medical devices into risk classes according to EU Regulation MDR 2017/745.

Putting a medical device on the market - creation of technical documentation, creation of risk analysis.

Putting a medical device on the market creation of technical documentation, information provided by the manufacturer (draft instructions for use, labeling of the medical device).

Clinical evaluation of medical devices processing of clinical evaluation.

Process requirements and service documentation according to the applicable law on medical devices, work with the register of medical devices.

Metrological system design of a metrological system in a medical facility, verification and calibration of meters.

Health Services Act analysis of the procedure for establishing a non-state health facility in the Czech Republic.

Rights and obligations of patients. Medical documentation.

Health care reporting and reimbursement options.

Search in the databases of the industrial property office (patents, utility models, trademarks).

Study Objective:

Study materials:

Note:

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:

• Systematic Integration of Prosesses of Healthcare (compulsory course)