Možnost uporabe lastno razvitih metod za laboratorijsko diagnostiko na osnovi Direktive 98/79/ES in Uredbe (EU) 2017/746

Hafner, Katarina (author), Božič, Borut (mentor)

Iztekajo se prehodna obdobja, ko bo na področju EU za in vitro diagnostične medicinske pripomočke začela v celoti veljati Uredba (EU) 2017/746. Namen magistrske naloge je bil sistematičen pregled in primerjava zakonskih predpisov na področju Slovenije in EU, ki so za in vitro diagnostične medicinske pripomočke veljali v preteklosti in ki so trenutno v veljavi, s spremembami, ki jih prinaša uredba, predvsem glede uporabe lastno razvitih (internih) metod. Lastno razvite metode in pripomočki imajo namreč izreden pomen pri zagotavljanju enakovredne zdravstvene oskrbe za vse skupine pacientov, saj pogosto pokrivajo nišne preiskave, ki so pomembne za majhno število pacientov in za katere na tržišču ni ustreznih industrijsko izdelanih metod. Poleg tega pa so take metode hitreje odzivne, tako na razvoj znanosti, kot na potrebe družbe, kar se je pokazalo ob pandemiji Covid-19. Sistematični pregled smo izvedli s pregledom zakonodaje na spletnih straneh Ministrstva za zdravje in Javne agencije za zdravila in medicinske pripomočke, z uporabo iskalnih nizov in prednastavljenih filtrov v zbirkah pravnih aktov PisRS in IUS INFO ter v uradnih zbirkah pravnih aktov EUR-lex in Uradni list RS. Skupno smo pregledali 40 pravnih aktov slovenskega pravnega reda in 32 pravnih aktov pravnega reda EU. Za podrobni vsebinski pregled pa smo izbrali 8 pravnih aktov slovenskega pravnega reda in 4 pravne akte pravnega reda EU, ki smo jih kronološko uredili in pregledali določila za lastno razvite metode. Zakonodaja na področju in vitro medicinskih pripomočkov in s tem pogoji za uporabo lastno razvitih metod, je bilo na ravni EU v obdobju 25 let deležno velikih sprememb. Tudi v slovenskem pravnem redu opazimo obdobja pred vstopom Slovenije v EU, v času prilagajanja zakonodaje pravnemu redu EU in po vstopu v EU. Področje lastno razvitih metod je bilo v pregledovanem obdobju v Sloveniji različno urejeno, kar je v določenih obdobjih vnašalo veliko nepredvidljivost pri njihovi uporabi. Uredba prinaša novosti, ki naj bi poleg zagotavljanja prostega pretoka pripomočkov na področju EU in poenotenja področja med državami članicami, zagotovila tudi večjo varnost pacientov, tako ob uporabi industrijsko izdelanih pripomočkov, kot tudi pri uporabi lastno izdelanih metod. S svojimi določili pa prinaša vrsto izzivov za laboratorije oz. zdravstvene ustanove kot tudi za same države članice in celotno EU.

• Language: Slovenian
• Keywords: zakonodaja, in vitro diagnostični medicinski pripomočki
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2024
• PID: 20.500.12556/RUL-161664
• Publication date in RUL: 13.09.2024

Secondary language

• Language: English
• Title: The possibility of using self-developed methods for laboratory diagnostics on the basis of Directive 98/79/EC and Regulation (EU) 2017/746

Abstract

Transitional periods are coming to an end, during which the EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices will start to fully apply across the EU. The aim of the Master's thesis was to systematically review and compare the legal regulations in Slovenia and the EU, which have applied to in vitro diagnostic medical devices in the past and are currently in force, with the changes introduced by the regulation, especially regarding the use for self-developed (in-house) methods. Self-developed methods and devices are of great importance in ensuring equitable healthcare for all patient groups, as they often cover niche tests that are crucial for a small number of patients and for which there are no suitable industrially manufactured methods available on the market. Furthermore, such methods are more responsive to development of scientific advancements and the needs of society, as was evident during the Covid-19 pandemic. The systematic review was conducted by examining legislation on the websites of the Ministry of Health and the Agency for Medicinal Products and Medical Devices, using search strings and pre-set filters in the legal act databases PisRS and IUS INFO, as well as in the official online databases EUR-lex and Uradni list Republike Slovenije. In total, we reviewed 40 legal acts from the Slovenian legal system and 32 legal acts from the EU legal system. For a detailed content review, we selected 8 legal acts from the Slovenian legal system and 4 legal acts from the EU legal system, which we organized chronologically and reviewed for provisions on self-developed methods. The EU legislation in the field of in vitro diagnostic medical devices, and thus the conditions for the use of self-developed methods, has undergone significant changes over the past 25 years. We also observe different periods in the Slovenian legal system - before Slovenia joined the EU, during the adaptation of legislation to EU legislation and after joining the EU. The field of self-developed methods was in Slovenia in different periods of the reviewed period regulated differently, which at times introduced considerable unpredictability in their use. The Regulation (EU) 2017/746 introduces changes to ensure functioning internal market for in vitro medical devices within the EU and harmonizing the field among member states but also to provide greater patient safety, both when using industrially manufactured devices and self-developed methods. However, its provisions also present a number of challenges for laboratories and healthcare institutions, as well as the member states themselves and the entire EU.

• Keywords: legislation, in vitro diagnostic medical medical devices