Based on the positive feedback on the training course held by ÚNMZ on the EU Medical Device Regulation 2017/745 (MDR), the Czech Agency for Standardization (ČAS) announced a public procurement for the supplier of a qualification course for manufacturers, importers, distributors and authorized representatives of medical devices in autumn 2021. Porta Medica applied and was successful. The course is not a series of ad hoc seminars and training sessions. Rather, a steady group of participants continuously completes the entire course over a period of six semesters.
A new feature is the increased scope of the course, where the original capacity constraint allowed for a total of sixty participants in the MDR part of the course, divided into two groups. However, this capacity was hopelessly filled within a few hours after the announcement, so an additional 20% increase in the number of seats was agreed with the sponsor. These seats were also successfully filled. Another novelty was the creation of another separate group of thirty participants for the part of the course dedicated to the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Here the interest was somewhat lower, but the course was eventually filled.
The course is designed in such a way that in the spring semesters there is always a seminar for the top management of the organisations that send representatives to the course. The aim of these seminars is to strengthen communication between regulatory staff and management representatives. At the same time, legislative and executive news are presented at the meetings in the form of a management summary. On the other hand, a specific feature of the autumn semesters is the annual conference, which also has a social dimension, as it is open to the wider professional public and is attended by representatives of government bodies. The main focus of all semesters is intensive training of participants, alternating expert lectures with interactive workshops.
The first semester of the MDR part of the course was successfully completed during January, despite the cresting wave of the covid variant Omicron. The IVDR area was then covered during the month of April. The main content of the introductory semester consisted of the legislative framework, basic concepts, legacy devices and the quality management system. At the end of the training, all participants took a regulatory test to verify that they had successfully acquired the necessary knowledge. The start of the course was therefore a success and we are already looking forward to the autumn semester.
Author: Jakub Král
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