ntr133-C_2022247EN.01000101-E0133
(133) As an exception, according to the legislation on medical devices and in vitro diagnostic medical devices the manufacturer must designate a person who is established in the Union to be responsible for the marketing of medical devices, if he does not have a registered place of business in a Member State and he places devices on the Union market under his own name. The Directive on Marine Equipment 2014/90/EU also requires the manufacturer who is not located in the territory of at least one Member State to appoint an authorised representative for the Union. A manufacturer established outside the EU may, for certain supply chains, also need an authorised representative to act as the economic operator referred to in Article 4 of Regulation (EU) 2019/1020.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.