Spremembe z uvedbo Uredbe o medicinskih pripomočkih MDR 2017/745 in smernice za pripravo poročila o uporabnosti kliničnega elektroporatorja za kožo

PERME, KATJA (author), Reberšek, Matej (mentor)

V današnjem času si obiska pri zdravniku, postavljanja diagnoze in posledično sodobnega zdravstva ne predstavljamo več brez medicinskih pripomočkov. Da bi razumeli, zakaj so spremembe, ki jih uvaja Uredba o medicinskih pripomočkov (MDR 2017/745), pomembne, smo v magistrski nalogi najprej obravnavali trenutni regulatorni okvir Evropske unije, ki posredno in neposredno vpliva na medicinske pripomočke. Spoznali smo, kaj je privedlo do sprememb v tem sektorju in izpostavili najpomembnejše spremembe, na podlagi katerih smo bralcu predstavili specifičnost področja. Sledili smo vrstnemu redu Uredbe in tako predstavili razlike na področju uporabe in pri opredelitvi pojmov. Spoznali smo obveznosti proizvajalcev in si področno pogledali razlike v klasifikaciji medicinskih pripomočkov, saj to neposredno vpliva na postopek ugotavljanja skladnosti. Pozornost smo namenili tudi priglašenim organom, identifikaciji pripomočka, kliničnim zahtevam in povzetku o varnosti in klinični učinkovitosti. Vsi medicinski pripomočki morajo biti skladni s splošnimi zahtevami glede varnosti in učinkovitosti, kar mora biti dokazano v tehnični dokumentaciji, zato smo v delu obravnavali tudi vsa ta področja. Na podlagi nove uredbe smo začrtali razvoj medicinskega pripomočka, natančneje razvoj kliničnega elektroporatorja za kožo, in izpostavili tiste točke v tehnični dokumentaciji, ki se nanašajo na uporabnost. V drugem delu magistrskega dela smo obravnavali pojem uporabnost, in sicer v kontekstu medicinskega pripomočka. Za dokazovanje njegove skladnosti s standardom, ki to področje opredeljuje, je treba pripraviti poročilo o uporabnosti. Tako so v tem delu pripravljene smernice za pripravo poročila o uporabnosti kliničnega elektroporatorja za kožo, v katerih je razložen vsak posamezen korak, ki je potreben za uspešno uporabo, in sicer po standardu IEC 62366-1:2015, poleg navedenega pa so izpostavljeni tudi primeri.

• Language: Slovenian
• Keywords: Medicinski pripomočki, Uredba o medicinskih pripomočkih 2017/745, Direktiva o medicinskih pripomočkih 93/42/EGS, Uporabnost, Poročilo o uporabnosti, IEC 62366-1
• Work type: Master's thesis/paper
• Organization: FE - Faculty of Electrical Engineering
• Year: 2020
• PID: 20.500.12556/RUL-120778
• Publication date in RUL: 25.09.2020

PERME, KATJA, 2020, Spremembe z uvedbo Uredbe o medicinskih pripomočkih MDR 2017/745 in smernice za pripravo poročila o uporabnosti kliničnega elektroporatorja za kožo [online]. Master’s thesis. [Accessed 14 April 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=120778

Secondary language

• Language: English
• Title: Changes introduced by Medical Devices Regulation MDR 2017/745 and guidelines for usability engineering file for a clinical skin electroporator

Abstract

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.

• Keywords: Medical devices, Medical Devices Regulation 2017/745, Medical Devices Directive 93/42/EEC, Usability, Usability engineering file, IEC 62366-1