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.
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