{"id":18097,"date":"2022-03-21T11:54:35","date_gmt":"2022-03-21T10:54:35","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=18097"},"modified":"2023-06-23T11:42:57","modified_gmt":"2023-06-23T09:42:57","slug":"european-authorised-representative-service","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/","title":{"rendered":"European Authorised Representative"},"content":{"rendered":"
<\/p>\n
\n
\"European
European Authorised Representative service<\/figcaption><\/figure>\n<\/div>\n<\/p>\n

Are you a non-European
Manufacturer<\/strong> and need to export<\/strong> your Medical Device<\/strong> in Europe<\/strong>?<\/p>\n<\/p>\n

According to MDR (EU) 2017\/745 and IVDR (EU) 2017\/746 Regulations and starting from May 26, 2021<\/strong> if your Company doesn\u2019t have a physical location in Europe, you must appoint a European Authorised Representative<\/strong>.<\/p>\n<\/p>\n

An European Authorised
Representative must be a physical or legal person established in one of the EU
Countries, that is expressly designated by the Manufacturer and contact
reference of the Competent national Authorities on behalf of the Manufacturer.<\/p>\n<\/p>\n

The EU Authorised Representative is legally
liable<\/strong> for defective devices on the same basis as, and jointly and
severally with, the Manufacturer in case the latter acts not in compliance with
the obligations stated by the regulations (Art. 10). The EU Rep contact details appear on the
device label and in Eudamed.<\/p>\n<\/p>\n

As your
European Authorised Representative Thema can be in full compliance with
articles 11 and 12 of the MDR\/IVDR and assure the compliance of your devices to
the regulations as Thema:<\/p>\n<\/p>\n