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17ABBZLN - Legislation in Health Care and Technical Standards

Code Completion Credits Range Language
17ABBZLN KZ 2 1P+1S English
Lecturer:
Vojtěch Kamenský, Peter Kneppo (guarantor), Ondřej Gajdoš
Tutor:
Vojtěch Kamenský, Ondřej Gajdoš
Supervisor:
Department of Biomedical Technology
Synopsis:

Health Services Act. Act on Professional Qualification for the Pursuit of the Medical Profession and on Further Education in Health Care (the Act on Medical Professions) and its implementing decrees. EU directives on medical devices. Act on Technical Requirements for Products. Government Regulation to the Act on Technical Requirements for Products. Structure of institutions dealing with the creation of technical standards in the Czech Republic and in the world. Technical standards relating to medical devices. Atomic law. Procedures for placing new medical devices on the market. Clinical testing of instruments. The role of testing laboratories. Some facts and experiences from abroad. Legislation on Good Manufacturing, Laboratory and Clinical Practice (GMP, GLP and GCP).

Requirements:

1. Participation in exercises - max. 1 absence

2. During the semester, students work on individual model tasks on individual topics. From these tasks it is possible to get points for the final evaluation. Max. 10 points for each exercise - min. 5 points for each.

3. Optional oral exam - max. 30 points.

Syllabus of lectures:

1. Introduction to the subject requirements. IThe Act on Health Services as amended. Act on non-medical health professions as amended.

2. General requirements for placing of medical devices on the EU market. Technical standardization.

3. Medical Device Regulation I - Basic principles of placing medical devices on the market. Rights and obligations of entities when the medical devices are placing on the market.

4. Medical Device Regulation II - Technical Documentation.

5. Use of medical devices in practice - service of, STC, specifics of the use of medical devices in the Czech Republic.

6. Medical Device Regulation II - Medical Device Vigilance System and post-market monitoring.

7. The Metrology Act as amended. Metrological system in the Czech Republic. Legal metrology in health care, metrological confirmation. Hospital Metrology Regulations. Metrology of quality management system.

Syllabus of tutorials:

1. Activities of biomedical technician. Ethics in biomedicine.

2. Technical standards in healthcare - focus on medical devices.

3. Classification aof medical devices.

4. Clinical evaluation of medical device - final report of Clinical Evaluation.

5. Risk Analysis.

6. Reporting of adverse events.

7. Provision of metrological order in health care providers.

Study Objective:

The aim is to acquaint students with the rights and obligations arising from current legislation related to health care. Emphasis is not placed on memorizing the literal wording of legislation, but on acquainting students with the main points and ideas contained in the laws, regulations and standards of the Czech Republic and EU directives in the field of health care. After completing the course, the student should have a comprehensive overview of health legislation.

Study materials:

[1] POMMELIN, Petri. The Survival Guide to Eu Medical Device Regulations. Books On Demand, 2017. ISBN 9789515681201.

[2] EXTER, André den a Tamara HERVEY. European Union Health Law: Treaties and Legislation. Antwerpen -

Apeldoorn: Maklu, 2012. ISBN 978-90-466-0544-8.

[3] GRONDEN, Johan Willem, Erika SZYSZCZAK, Ulla NEERGAARD a Markus KRAJEWSKI. Health Care and EU

Law: Legal Issues of Services of General Interest. Hague: T.M.C. Asser Press, 2011. ISBN 978-90-6704-727-2.

European regulations

- data.europa.eu/eli/reg/2017/745/oj

- data.europa.eu/eli/reg/2017/746/oj

Database of harmonized standards

- www.nlfnorm.cz/en/normy/475/databaze-harmonizovanych-norem-477

EudaMed

- www.eudamed.eu

Note:
The course is a part of the following study plans:
Downloads:

Lectures - link: 

Exercises - link: