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F7ABBZLN - Legislation in Health Care and Technical Standards

Code Completion Credits Range Language
F7ABBZLN KZ 2 1P+1C English
Lecturer:
Tutor:
Supervisor:
Department of Biomedical Technology
Synopsis:

Aims / aims: The aim of the course Legislation in Health Care and Technical Standards is to teach students the basic requirements and regulatory obligations in healthcare, especially in the field of medical devices. During the course, students will learn the basics of legislation process, as well as regulation related to the medical devices, lso with legislative regulations in the field of clinical trials and the operation of medical devices. Furthermore, students will learn the legal context of providing health care. The aim is to acquaint students with the rights and obligations arising from current legislation relating to health care issues.The emphasis is not on memorizing of the text of legal regulations, 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 healthcare.

Prerequisites and co-requisites: To successfully complete the course, students should know the basics of the principles of medical devices due to the practical application of legislation in this area.

Output knowledge, skills, abilities and competences: After completing the course, the student should have a comprehensive overview of health legislation. He should be able to orientate himself in a given problem related to legislation without any problems and he should know where he can find individual details related to legal issues in health care.

Requirements:

During the semester, students work on independent model assignments on individual topics. These assignments can be used to earn points for the final

assessment (max. 70 points). In addition, students must complete the oral part of the graded credit (max. 30 points). Questions for the oral part are posted on the course website during the semester. Students must earn a minimum of half points on each part.

Syllabus of lectures:

1. Fundamentals of law. Principles of law and administrative process. Types of legal norms (binding standards, harmonized standards, specified standards). Principle of health legislation. EU legislative system - types of legislative documents and their binding force, ie EU directive - laws - government regulations.

2. Current Act on Medical Devices. Putting medical device on the market. Clinical evaluation of medical devices. Maintenance and service of medical devices. Notification and reporting obligation. Classification of medical devices. Recommendations and interpretative documents MEDDEV.

3. Current law on technical requirements for products. Ensuring the conformity of medical devices. Declaration of conformity.

4. System of technical standardization. Standards in healthcare. Basics of creating standards. Binding, harmonized and specified standards. Search for standards. Working with the standard.

5. Current Act on Metrology. Metrological system in the Czech Republic. Legal metrology in healthcare.

6. Legal context of providing of health care. Current Act on Health Services. Medical

facilities in the Czech Republic, medical documentation. health registry.

7. Quality management system. Basic classification of management process. Principles of quality management according to ISO. Accreditation, certification. Clinical laboratories. Atomic law. Current Act on Non-Medical Health Professions.

Syllabus of tutorials:

1. Employment contract. Establishment of a trade. DPČ and DPP. Termination of employment.

2. Current Medical Devices Act - Classification of medical devices. Safety technical inspection.

3. Clinical evaluation.

4. Placing a medical device on the market.

5. Work with the standard. Binding, harmonized and specified standards. Standards for medical technology.

6. Current Act on Metrology. Determined and unspecified meters. Verification and calibration. Calibration curve.

7. Accreditation of medical facilities.

Study Objective:

The aim of the course Legislation in Health Care and Technical Standards is to teach students the basic requirements and regulatory obligations in healthcare, especially in the field of medical devices.

Study materials:

Compulsory literature:

[1] Medical Devices [online]. Belgium, Brussels. 1990. [cit. 07-05-2019]. Available from:

https://ec.europa.eu/growth/sectors/medical-devices_cs?2nd-language=pl

[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) [online]. Belgium, Brussels. 2017. [cit. 05-05-2019] Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

Recommended literature:

[1] European Union health law: treaties and legislation. Editor André den EXTER, editor Tamara K. HERVEY. Apeldoorn: Maklu, 2012. ISBN 978-90-466-0544-8.

[2] SÚKL – State Institute for Drug Control [online]. Czech Republic, Prague. 2010. [cit. 07-05-2019]. Available from: http://www.sukl.cz

[3] NISZP – Legislation – Act on Medical Devices [online]. Czech Republic, Prague. 2018. [cit. 07-05-2019]. Available from: https://www.niszp.cz/en/legislation/act-medical-devices

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