MDR REGULATION - LEGAL HARMONIZATION STEPS

For the purposes of legal harmonization, amendments to several laws impacted by Medical Device Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/7461 of the European Parliament and Council were published in the Hungarian Gazette Magyar Közlöny on August 16, 2021, stipulated in Order No. 35/2021 (VIII.16.) of the Ministry of Human Resources.  

Previously, rules on medical devices were governed by Directive 93/42/EEC and in vitro diagnostic medical devices by Directive 98/79/EC. After more than two decades, they were replaced by the above-referenced EU regulations. EU regulations regulate, among many other subjects, market entry of products and the general obligations of manufacturers, importers, distributors, the EU declaration of conformity and the CE conformity marking, as well as safety requirements. These EU regulations cover technically all essential aspects of the licensing and manufacturing of medical devices.

Due to the hierarchy of legal sources and the primacy of EU legislation, Hungary had the obligation to ensure legal harmonization with these regulations in order to provide compliance. For the protection of patient health and due to the Covid-19 pandemic, the European Parliament and Council last year postponed the entry into force of the regulations until May 26, 2021.

Please note that no significant legislative changes were introduced by the Order of the Ministry of Human Resources, mainly the therein used definitions, terms and legal texts were harmonized.