Importer & Authorized Representation for
Medical Device & IVD
Manufacturers Exporting to the EU, UK & Switzerland
EU MDR & IVDR
Importer
Required for compliance with Article 13 of the EU MDR and IVDR.
Great Britain
(UK) Importer
Required for compliance with new UK MHRA requirements.
Swiss
Importer
Required for compliance with new Swissmedic requirements.
Swiss
Authorized Rep
Required for all manufacturers exporting to Switzerland.
We Help Manufacturers Meet New European Regulatory Requirements While Maintaining Commercial Control
300+ Medical Device & IVD Manufacturers
Trust MedEnvoy as Their Importer
New medical device and IVD regulations in the European Union, UK and Switzerland impose strict new requirements on manufacturers and elevate the role of the importer (Economic Operator) in placing devices on these markets. The regulatory Importer is similar to an EU Authorized Representative, and you must appoint one. There are many reasons to select an independent, professional importer service company such as MedEnvoy to act as your single independent importer for all European markets.
Europe's #1 Regulatory Importer for Medical Devices & IVD Manufacturers
Our team has been assisting medical device and IVD manufacturers with compliance for decades. We fully understand the need to maintain the smooth operation of your European supply chain while meeting the new regulatory requirements imposed by the European Commission, UK MHRA and Swissmedic. Our standardized and proven processes will help you meet European regulations without disrupting the way you do business today.
