Importer & Representation Services for
Medical Device & IVD
Manufacturers Exporting to the EU, UK & Switzerland

EU MDR & IVDR
Importer

Required for compliance with EU MDR/IVDR Article 13.

Great Britain
(UK) Importer

Required for compliance with new UK MHRA requirements.

Required for compliance with new Swissmedic requirements.

EU Authorized Representative

Required under Article 11 of the EU MDR/IVDR.

UK Responsible Person (UKRP)

Required for selling in England, Scotland and Wales.

Swiss Authorized Rep (CH-REP) 

Required for all companies without a location in Switzerland.

We Help Manufacturers Meet New European Regulatory Requirements While Maintaining Commercial Control

550+ Medical Device & IVD Manufacturers
Trust MedEnvoy as Their Importer or Representative

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.

Convenient. Consistent. Responsive.

Three European Markets. One Trusted Partner.

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. 

MedEnvoy is ISO 13485:2016 certified! View our certificate.