New Obligations of Medical Device Distributors under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Patryk Kałczyński
Office of Legal Adviser Patryk Kalczyński , Polandhttps://orcid.org/0000-0002-0891-7716
Abstract
The aim of this article is to present the obligations of distributors who are among the most important economic operators participating in the circulation of medical devices. Medical devices are becoming increasingly important not only due to the COVID-19 pandemic. The constantly growing market of this product group but, above all, the level of risk that medical devices carry for the health and life of patients and users required the European Legislator to ensure a uniform and high level of protectionfor the above goods. This task is to be fulfilled by Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, which is a part of the new legislative framework for placing products on the European Union market. The aforementioned legal act replaces the regulations that have been in force for almost 30 years in this area and represents a certain revolution for distributors in terms of their participation in the system for ensuring the safety of medical device marketing.
Keywords:
MDR regulation, medical devices, distributorReferences
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Office of Legal Adviser Patryk Kalczyński https://orcid.org/0000-0002-0891-7716
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
This work is licensed under a Creative Commons Attribution 4.0 International License.
