Helping Manufacturers Meet Article 13 of the EU MDR and IVDR While Maintaining Full Commercial Control, Independence and Maximum Flexibility
The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) impose strict new requirements on device manufacturers and define the roles of "Economic Operators." Manufacturers without a location in the EU must now work through an Importer.
While your importer could be an EU-based distributor, there are good reasons to select a company like MedEnvoy to act as your single independent EU MDR/IVDR Importer.
medical devices & IVDs
Based in The Netherlands, importing hub of Europe
EU MDR (2017/745) and
IVDR (2017/746) expertise
Focused on Medical Devices & IVDs Since 2005
We are no strangers to the medical device industry. Our team has been actively helping device companies worldwide with distribution-related issues since 2005. You can be assured that we fully understand the complexities of European distribution and the new regulatory requirements that take hold in May 2021. We are ready to help you maintain compliance and the seamless flow of your products into the European Union.