450-4074/01 – Certification of Medical Devices (CZP)

Gurantor departmentDepartment of Cybernetics and Biomedical EngineeringCredits3
Subject guarantorIng. Lukáš Peter, Ph.D.Subject version guarantorIng. Lukáš Peter, Ph.D.
Study levelundergraduate or graduateRequirementCompulsory
Year2Semesterwinter
Study languageCzech
Year of introduction2019/2020Year of cancellation
Intended for the facultiesFEIIntended for study typesFollow-up Master
Instruction secured by
LoginNameTuitorTeacher giving lectures
PET497 Ing. Lukáš Peter, Ph.D.
Extent of instruction for forms of study
Form of studyWay of compl.Extent
Full-time Credit and Examination 2+1
Part-time Credit and Examination 12+0

Subject aims expressed by acquired skills and competences

The aim of the course is to deepen and update knowledge in the field of management and management system for medical devices. Most of the subject is devoted to the certification and registration of medical devices in the EU and outside the EU according to valid legislation. Upon completion of the course the student will be familiar with basic concepts in the field of medical technology management, mainly from the point of view of the manufacturer of medical technology. The student will know how to work with European regulations, standards and recommended papers so that all the requirements for certification and registration of medical devices in the EU are met. Part of the subject also deals with requirements for certification and registration of medical devices outside the EU. This subject focuses mainly on the necessary legislation in the field of certification and registration of medical devices.

Teaching methods

Lectures
Individual consultations
Tutorials
Project work

Summary

The subject "Certification of Medical Devices" will deepen the basic information on legislation related to medical devices - ZP. The lessons are focused on a deeper understanding of the ISO work related to the ZP and, to a large extent, on the certification of the ZP from the point of view of the manufacturer, but also partly from the point of view of medical devices. From the point of view of the necessary procedures and requirements for certification of the ZP, all necessary documents necessary for conformity assessment by the notified body are discussed in the EU and also outside the EU as well as the individual procedures for the creation of such documents.

Compulsory literature:

Presenattion of lectures MDR 2017/745.The EU Medical Devices Regulation, 2017, 175 p. LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.

Recommended literature:

ISO 13485:2016. Medical devices -- Quality management systems -- Requirements for regulatory purposes. International Organization for Standardization, 2016. 36 p. ISO 14971:2007. Medical devices -- Application of risk management to medical devices. International Organization for Standardization, 2007. 82 p. COUNCIL DIRECTIVE 93/42/EEC concerning medical devices, 1993, 58 p. Another regulatory documents

Way of continuous check of knowledge in the course of semester

3 tests during the semester, semester project, oral examination

E-learning

Other requirements

no further student requirements are required

Prerequisities

Subject has no prerequisities.

Co-requisities

Subject has no co-requisities.

Subject syllabus:

Lectures and Exercises 1.First hour • Laws on Medical Devices 2. Basic Documents • MDD, Relevant Standards, EC Directive, MEDDEV 3.Registration and Certification of Medical Devices in the EU • Requirements, Procedure 4.Management of medical devices from the point of view of the hospital • MDD 2017/745, SÚKL, VZP, Notified Body, Notification, Accreditation 5.Management of health products from the manufacturer\'s perspective • MDD 2017/745, SÚKL, VZP, Notified Body, Certification, Registration, Declaration of Conformity 6.Management system for manufacturers • Structure, Application of EN ISO 13485: 2016, PMS, PMCF, Document updates 7-8.Technical documentation • Technical Component, Conformity Assessment, Usability of Medical Devices, Medical Device Instruction, Testing of Medical Devices, Validation and Verification of the Life Cycle of a Medical Device, Validation and Verification of Software 9. Clinical evaluation of medical devices • Preclinical Evaluation, Clinical Evaluation, Clinical Evaluation Plan, Ethics Committee 10.Biological evaluation • Biological assessment plan, ČSN EN ISO 10993, Biocompatibility 11. Risk management and risk analysis for medical devices • Content of the standard ČSN EN ISO 14971: 2012 12-14.Registration of medical devices outside the EU • FDA, ASIA, SOUTH AMERICA, AUSTRALIA

Conditions for subject completion

Part-time form (validity from: 2019/2020 Winter semester)
Task nameType of taskMax. number of points
(act. for subtasks)
Min. number of pointsMax. počet pokusů
Credit and Examination Credit and Examination 100 (100) 51
        Credit Credit 40  20
        Examination Examination 60  31 3
Mandatory attendence participation: Attendance at lectures and exercises is at least 85% - checked by attendance on sign-up sheets. A minimum of 20 exam points is required to successfully complete for continuing the exam. A minimum of 31 exam points is required to successfully complete the subject.

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Conditions for subject completion and attendance at the exercises within ISP: Completion of all mandatory tasks within individually agreed deadlines.

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Occurrence in study plans

Academic yearProgrammeBranch/spec.Spec.ZaměřeníFormStudy language Tut. centreYearWSType of duty
2024/2025 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2024/2025 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan
2023/2024 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2023/2024 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan
2022/2023 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2022/2023 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan
2021/2022 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2021/2022 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan
2020/2021 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan
2020/2021 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2019/2020 (N0988A060001) Biomedical Engineering LPT P Czech Ostrava 2 Compulsory study plan
2019/2020 (N0988A060001) Biomedical Engineering LPT K Czech Ostrava 2 Compulsory study plan

Occurrence in special blocks

Block nameAcademic yearForm of studyStudy language YearWSType of blockBlock owner

Assessment of instruction



2023/2024 Winter
2022/2023 Winter
2021/2022 Winter
2020/2021 Winter