Let us act as your European Authorized Representative.
Why an AR is Needed
An overview of who needs to hire an EU Authorized Representative and what regulations require it.
Why Choose Emergo Europe
Why hundreds of device companies have chosen Emergo Europe as their Authorized Representative
What We Do On Your Behalf
Services we perform on your behalf and why it makes sense to hire a regulatory professional.
Most Common Questions
Answers to questions commonly asked about the roles and responsibilities of the Authorized Rep.
Are you a medical device or IVD company looking for a firm to act as your Authorized Representative for Europe? You have come to the right place. Emergo Europe, a division of Emergo Group, Inc., is one of the largest Authorized Representatives in the EU, representing hundreds of medical device and IVD companies worldwide.
Unlike many Authorized Representatives, we have offices in the USA and Europe, allowing you to receive fast service regardless of your time zone. Plus, we offer many services beyond Authorized Representation including CE Mark consulting, ISO 13485 and GMP quality system implementations, Technical File construction, FDA US Agent representation, Japan PAL compliance, China SFDA approvals, medical distribution management and more.
