The entry into force of the free trade agreement between the European Union and the Republic of Korea on July 1, 2011 (EFTA) eliminated customs duties on 98.7% of products and removed non-tariff barriers to the export of key goods between them. The agreement in question is in many respects a pioneering solution both due to the broad subject of regulation and the degree of liberalization of trade, but also due to the fact that it is the first free trade agreement concluded by the European Union with an Asian country and the first so-called "next generation". Thanks to the implementation of the provisions of the agreement, the parties managed not only to reverse the negative balance of bilateral trade, but also to change the material structure of imports and exports of goods, among which medical devices play an increasingly important role, together with pharmaceutical products generate an annual trade surplus of EUR 60 billion. This article analyzes the functioning of the medical device market in the context of EFTA EU-Republic of Korea pointing to the need for the parties to take steps to harmonize medical device certification standards with particular emphasis on the potential of MDSAP