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Three-year qualification course for MDR and IVDR

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We would like to inform you that the Czech Agency for Standardization is organizing a three-year qualification course on the EU Medical Device Regulation 2017/745 (MDR) and EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), which will take place between January 2022 and December 2024.

Porta Medica is the supplier of this six-semester course, which is intended for regulatory personnel of medical device manufacturers and other operators handling medical devices. The focus and scope of the course is not intended for representatives of educational and consulting companies, students or academics. The course is implemented on the basis of requests and suggestions from industry associations and with the support of the Ministry of Industry and Trade.

Participation in the course is free of charge. Only the fee of 990 CZK excluding VAT for additional services per person per day of training, conference or seminar is payable. The MDR and IVDR areas are separate in the course. The professional attends either the MDR or the IVDR course.

If you are interested, please send the completed application form in machine-readable form (MS Word or a copyable PDF, not a scan), separately for each participant to jana.kazdova@portamedica.cz

The total number of participants is limited to a maximum of two professionals per company. Applicants will be placed on the course in order of date and time of application.

CAS course - IVDR - application

CAS course - IVDR - invitation

CAS course - MDR - application

CAS course - MDR - invitation