Interested in obtaining CE certification so you can sell your medical devices in Europe? If your company does not have a physical location within the EU, the CE Marking Directives require you to appoint an Authorized Representative (AR), also referred to as an EC Rep.
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 EC Rep will:
- Make a current copy of your Technical File 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
- Assist with certain device registrations, as required
- Be identified on your product labeling
While it is possible to appoint a distributor to serve as your Authorized Representative in Europe, it is recommended to select an independent EC Rep that will be focused 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?
We are the largest Authorized Representative for medical devices and IVDs, representing more than 1,000 medical device companies worldwide.
- Our experienced consultants will conduct a review of 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 regarding Technical Files, Labeling Information and Symbols, Language Requirements, Directives, Guidelines and more.
- Our expertise in the European regulatory environment helps ensure a smooth and efficient registration process.
- We send monthly 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 package for new European representation clients.