A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance …

2023年11月23日 · Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the …

What does the EU Authorized Rep do? Does the EU AR need to be on the device label? What about the United Kingdom and Switzerland? A European Authorized Representative (EU AR) …

Below is a list of Representation offices by country. Commission representations perform various functions such as liaising with local authorities and media, organising official visits, and …

What is an EU authorised representative? An EU authorised representative is any natural or legal entity established within the European Union who has accepted a written mandate from a non …

European authorized representative (EC REP) for medical device and IVD companies. Official EU Authorized Representative for 1,000+ manufacturers worldwide.

A legal company registered in the EU has professional technical personnel, familiar with relevant EU regulations, and can help manufacturers resolve disputes. Sign a valid EU authorized …

Are you a manufacturer of medical devices based in a country outside the EU? Then, according to MDR / IVDR, you need an EU authorised representative (EC-REP), to legally sell your …

Qserve can act as EU Rep for medical devices certified under the EU MDD and MDR as well as in vitro diagnostics certified under the IVDD and IVDR. We also act as UK Responsible Person, …

One such requirement is the appointment of an EU Authorized Representative, also known as an EU Rep. Here’s why an EU Rep is essential and how you can secure this service to ensure …