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CZECH TECHNICAL UNIVERSITY IN PRAGUE
STUDY PLANS
2019/2020

Legislation in Health Care and Technical Standards

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Code Completion Credits Range Language
17ABBZLN KZ 2 1P+1S
Lecturer:
Vojtěch Kamenský, Peter Kneppo (guarantor), Ivana Kubátová
Tutor:
Vojtěch Kamenský, Anna Erfányuková, Jana Chocholatá, Ivana Kubátová
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:

Attendance at external lectures

1. Participation in exercises - max. 1 absence

2. Tasks will be elaborated for the exercises - the topic will always be set a week in advance. Students prepare for the exercises so that they can solve tasks on the topic - without using the Internet and notes. Only legal regulations will be available.

3. Max. 10 points for each exercise - min. 5 points for each.

4. Optional oral exam - max. 30 points.

Syllabus of lectures:

1. Introduction to the subject requirements. Introduction to legislation in general (types of regulations, links to EU legislation, creation and adoption of legislation.

2. Structure of legislation in health care, the Act on Health Services as amended. Act on non-medical health professions as amended.

3. Creation of technical standards. System of technical standardization (system, creation, Czech and international standards, labeling). Harmonized and specified standards. The most commonly used standards for medical devices.

4. Act on Medical Devices as amended. Government regulation related to it. EU MDR Regulation. Compare current status with „MDR“.

5. Clinical evaluation. Risk analysis. Quality management system. Interconnection of quality management systems with „MDR“.

6. 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.

7. Atomic law, radiation protection in health care.

Syllabus of tutorials:

1. Rights and duties of biomedical technician. Ethics in biomedicine.

2. Application of technical standards in health care.

3. Classification and clinical evaluation of medical devices.

4. Technical documentation and declaration of conformity.

5. Use of medical devices in practice.

6. Application of ISO 9001 and 13485 standards for medical devices.

7. Determined and unspecified gauges. Verification and calibration. Calibration curve.

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:
Time-table for winter semester 2019/2020:
06:00–08:0008:00–10:0010:00–12:0012:00–14:0014:00–16:0016:00–18:0018:00–20:0020:00–22:0022:00–24:00
Mon
roomKL:B-433
Kamenský V.
Kubátová I.

12:00–13:50
ODD WEEK

(lecture parallel1)
Kladno FBMI
Lab. model. ve zdravotnictví
Tue
roomKL:B-334
Kamenský V.
12:00–13:50
ODD WEEK

(lecture parallel1
parallel nr.1)

Kladno FBMI
Lab. nemoc. infor. systémů
Fri
Thu
Fri
Time-table for summer semester 2019/2020:
Time-table is not available yet
The course is a part of the following study plans:
Data valid to 2020-02-21
For updated information see http://bilakniha.cvut.cz/en/predmet2184606.html