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) …

Your EU Authorised Representative (EC REP) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of …

The European Authorized Representative (EC REP) performs certain duties under the European Medical Devices Regulations and acts as the legal interface between the Medical Device …

If your company does not have a physical location in Europe, you are required to appoint an Authorized Representative (also referred to as an EC REP or AR) to represent your company …

2021年10月15日 · What is an Authorised Representative (EC REP)? Essentially, an EC REP plays an intrinsic part in post-market surveillance, including vigilance. The Authorised …

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 …

2022年2月21日 · Medical device labeling requirements for the EU & Swiss Authorized Representatives and UK Responsible Person: where the info must appear & which symbols to …

An EC Rep is an individual or entity appointed by a manufacturer located outside the European Union (EU) to act as their representative within the European Economic Area (EEA).

It determines that all non-EU manufacturers need to appoint a European Authorized Representative (EC-REP) when launching a Medical Device on the EU-market. As your EC …

For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) mandate that non-EU manufacturers appoint an authorized representative based in the EU. This …