450-4074/01 – Certification of Medical Devices (CZP)
| Gurantor department | Department of Cybernetics and Biomedical Engineering | Credits | 3 |
| Subject guarantor | Ing. Lukáš Peter, Ph.D. | Subject version guarantor | Ing. Lukáš Peter, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 2 | Semester | winter |
| | Study language | Czech |
| Year of introduction | 2019/2020 | Year of cancellation | |
| Intended for the faculties | FEI | Intended for study types | Follow-up Master |
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
Additional study materials
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
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction