Selling products within the European Union must comply with the EU-regulations MDR and IVDR. Especially non-EU manufacturers are forced to appoint an EC-REP. A compliance with EU regulations allows EU and non-EU manufacturers to sell their medical products in many other countries of around the world. Therefore they need a a so called Free Sales Certificate that is issued by an EU competent azthority. MedNet helps you as manufacturer to gain access to other countries worldwide with a Representation within the EU and a Free Sales Certificate.
Manufacturers who want to apply for a Free Sales Certificate must comply with the EU regulations. We support you by offering following services:
As your Authorized Representative MedNet EC-REP supports EU-based manufacturers of IVD and medical devices to apply for a Free Sales Certificate and assists you with additional services.
Non-EU manufacturers are forced to appoint an European Authorized Representative to sell their products in the European Union.
To obtain a Free Sales Certificate these products have to adhere to EU regulations.
We offer a range of services to support non-EU manufacturers in this process, including:
As your European Authorized Representative, MedNet EC-REP is dedicated to assisting non-EU-based manufacturers of IVD and medical devices in their pursuit of a Free Sales Certificate asd well as offering a range of supplementary services to facilitate the process.