European Authorized Representative for Medical Device Companies

ANSWERED ON THIS PAGE:

• What are the responsibilities of an EU Authorized Representative (EC REP)?
• Can I appoint a distributor as my representative?
• What happens if I want to change my EC REP?

Interested in obtaining CE certification to sell your medical devices in Europe? If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative, also referred to as an EC REP, to represent your company to European authorities. You must retain an EC REP as long as you sell your devices in Europe.

What is the role of an EU Authorized Representative?

Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:

• Assist with certain device registrations, as required
• Be identified on your product labeling throughout Europe
• Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
• Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors

It is possible to appoint a distributor as your Authorized Representative in Europe, but it is not recommended because most distributors are not prepared to fulfill the mandatory responsibilities of the EC REP. Instead, select an independent representative that will focus on regulatory affairs, rather than sales and marketing. Read more about the benefits of hiring an independent firm to act as your EC REP in Europe.

Why choose Emergo as your European Authorized Representative?

Emergo is the largest Authorized Representative for medical devices and IVDs, representing more than 1,000 device companies worldwide.

• Our experienced consultants will review your Technical File, register your medical device or IVD, as required, and respond to any questions or concerns from the Competent Authorities.
• You will have secure online access to all of your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines, and more.
• Our vast expertise with European regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
• We send frequent updates to all of our Authorized Representation clients with important regulatory updates focused on Europe.
• In addition to our European offices, we maintain offices in the US, Canada, Japan, Korea, Brazil, and many other places worldwide. We can serve you efficiently regardless of your time zone.

Ask us about our special 3-year and "deferred payment" packages for new European representation clients.