THE ISSUE OF UNIFORM APPLICATION OF PROVISIONS ON MEDICAL DEVICES IN THE EU ON - CASE POLAND

Bartlomiej Zylka

Abstract


The import and introduction of medical devices to the common market of the European Union constitutes a significant part of the community's trade exchange with the world. In this context, the harmonization of regulations relating to medical devices has become one of the key elements of the trade, medical, and customs policy of the European Union. This article briefly outlines the evolution of the Community regulations on medical devices and indicates some problems that are important from the point of view of members of the economic market, which may arise at the stage of application of regulations on medical devices by state administration bodies, as well as the related legal and business consequences. The analysis focuses on the two legal acts which are of key importance from the point of view of qualifying devices as medical Directive 93/42/EEC on medical devices (MDD), applicable from 1 January 1995 until 25 May 2021, Regulation (EU) 2017/745 on medical devices (MDR), fully applicable from 26 May 2021. Similarly, the role of public administration bodies in applying EU law is analyzed, and the related dangers to the principles on which the EU legal system rests are indicated. The issues raised constitute the basis for de lege ferenda conclusions, which focus on the possibility of unifying the practice of applying the law in the individual Member States through specific institutional solutions and thus eliminating potential particularisms.

Keywords


Medical devices, European Union, MDD, MDR, harmonization, administration.

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References


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