EU Authorized Representative for Medical Device Companies

Is your medical device or IVD firm searching for a company to act as your Authorized Representative (EC REP) for Europe? 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 Europe and North America, South America and Asia, allowing you to receive fast service regardless of your geographic location. Plus, we offer many services beyond Authorized Representation including CE Marking consulting, ISO 13485/GMP quality system implementation, Technical File/Design Dossier construction, FDA US Agent representation, Japan PAL compliance, China SFDA approvals, medical distribution management and more. For more information, see our overview of all Emergo Group QA and RA consulting services related to the US, Canada, Mexico, China, Japan, Europe, Russia, Brazil, South Korea and Australia.

Why an Authorized Representative is Required for CE Marking An overview of who needs to appoint an EU Authorized Representative and the regulations that require your company to do so.
Services We Perform as an Authorized Representative Services we perform on your behalf and why it makes sense to hire a professional, independent regulatory firm to represent your company in the European Economic Area and Switzerland.
Advantages of Selecting Emergo as Your EC REP in Europe See why hundreds of medical device and IVD companies worldwide have chosen Emergo Europe as their Authorized Representative.
Common Questions About Our Authorized Representation Services Answers to questions about the role and responsibilities of the EU Authorized Representative (EC REP).