Nowadays, we can no longer imagine a visit to the doctor, diagnosis and, consequently, modern healthcare without medical devices. In order to understand why the changes introduced by the Medical Devices Regulation (MDR 2017/745) are important, we first discussed in the master's thesis the current regulatory framework of the European Union, which directly and indirectly affects medical devices. We looked at what has led to changes in this sector and highlighted the most important ones, based on the specificity of this field. We followed the order according to the Regulation and thus presented the differences in the scope and definitions. We learned about the obligations of manufacturers and looked at the differences in the classification of medical devices, as this directly affects the conformity assessment process. Attention was also paid to notified bodies, device identification, clinical requirements and a summary of safety and clinical performance. All medical devices must comply with the general safety and performance requirements, which is then proven in the technical documentation, so we also touch all these areas, too. Based on the new regulation, we outlined the development of a medical device in the case of a clinical skin electroporator and highlighted the points in the technical documentation related to usability. In the second part of the master's thesis, we learn what usability in the context of a medical device actually is. If we want to demonstrate compliance with the standard IEC 62366-1: 2015, we need to prepare a usability engineering file. We prepared guidelines for usability engineering file for a clinical skin electroporator, where we explain each individual step required for the successful implementation of the usability engineering according to the standard IEC 62366-1: 2015.
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