Oprogramowanie medyczne jako wyrób medyczny. Wybrane zagadnienia prawno‑regulacyjne na tle rozporządzenia Parlamentu Europejskiego i Rady (UE) 2017/745 z 5 kwietnia 2017 roku.

Abstrakt

The aim of this paper is to analyze the changes introduced by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices regarding the qualification and classification of software as a medical device. The results of this analysis allow an attempt to answer the question of how far the new regulations ensure a balance between protecting the patient and user and ensuring the availability of innovative medical technologies. The assessment of the new regulations in the EU was made against the background of the regulations adopted for the approval of software as a medical device in the United States. Conclusions arising from the above assessment also include the author's proposal to amend the new regulations as a de lege ferenda postulate.