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ECTS Course Overview



Certification of Medical Devices

* Exchange students do not have to consider this information when selecting suitable courses for an exchange stay.

Course Unit Code450-4074/02
Number of ECTS Credits Allocated3 ECTS credits
Type of Course Unit *Optional
Level of Course Unit *Second Cycle
Year of Study *
Semester when the Course Unit is deliveredWinter Semester
Mode of DeliveryFace-to-face
Language of InstructionCzech, English
Prerequisites and Co-Requisites Course succeeds to compulsory courses of previous semester
Name of Lecturer(s)Personal IDName
PET497Ing. Lukáš Peter, Ph.D.
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.
Learning Outcomes of the Course Unit
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.
Course Contents
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
Recommended or Required Reading
Required Reading:
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.
Prezentace z přednášek
MDR 2017/745. NAŘÍZENÍ EVROPSKÉHO PARLAMENTU A RADY (EU) 2017/745, 2017, 175 p.
LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.
Recommended Reading:
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
ČSN EN ISO 13485 ed. 2. Zdravotnické prostředky - Systémy managementu kvality - Požadavky pro účely předpisů. Praha: Český normalizační institut, 2016. 56 p.
ČSN ISO 14971. Zdravotnické prostředky - Aplikace řízení rizika na zdravotnické prostředky. Praha: Český normalizační institut, 2012. 80 p.
MDD 93/42/EHS. SMĚRNICE RADY 93/42/EHS o zdravotnických prostředcích, 1993, 58 p.
Další platné předpisy a normy
Planned learning activities and teaching methods
Lectures, Individual consultations, Tutorials, Project work
Assesment methods and criteria
Tasks are not Defined