Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Eurasian medical device regulatory system - a new challenge or a new opportunity for European medical device manufacturers? ***

Elena Lang (Abschlußjahr: 2018)

Summary
Language: English
In April 2017, two new regulations in the medical device sector were adopted by the European Parliament and the Council and published in EU’s Official Journal in May 2017: Regulation (EU) 2017/745 for Medical Devices (MDR) and Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices (IVDR). The European manufacturers now are facing with the implementation of the increased requirements of the regulations.
But also outside of Europe, some regulatory changes take place. For example, on 6th May 2017, the single market for medicinal products and medical devices within the Eurasian Economic Union (EAEU) was officially launched. EAEU is for a lot of medical devices companies an interesting market place to sell their products.
The aim of this master’s thesis was to shed light to the new regulatory environment of the Eurasian medical device market and to discuss any specifics of the current requirements and the registration process.
Accordingly, contents of eighteen documents were considered and discussed with the inclusion of the author’s experience with the registration of medical devices on the Russian market.
The analysis of mentioned documents has shown that the Eurasian Commission which is responsible for the regulatory framework of the EAEU was guided by the international recognized documents and standards when preparing the EAEU regulatory documents.
Nevertheless, the new Eurasian medical device registration procedure presents new challenges for the European medical device manufacturers. Even if medical devices manufactured in the EU according to European requirements are mostly in line with the requirements of the EAEU, EU manufacturers should observe some additional aspects and additional requirements when registering their products in the Eurasian Union.
In conclusion, the author of this master’s thesis notes that while the development of the Eurasian market poses new challenges to the European manufacturers, it also opens up new opportunities through the formation on a single medical device market and the common legislation. Among other things, because a medical device manufacturer has to compile and to maintain only one medical device registration dossier and to deal with one competent authority only.
However, those who want to work with the region should have a lot of patience and understanding as well as Russian language skills because the majority of the concerned documents is available only in Russian.
Pages: 58
Annexes: pages: 22