European Authorized Representative for Medical Device Companies
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
Why choose REGCONSULT as your European Authorized Representative?
REGCONSULT is a highly specialized consulting company providing a full range of services to medical devices companies. With an experienced and dedicated professional team specialized in medical device regulation, quality systems and product development, REGCONSULT offers a comprehensive range of services, also acting as European Authorized Representative for MDD, IVDD, AIMDD, MDR, IVDR European regulatory affairs and CE Marking.
If you need to speak to someone right away, you can call us at +380 44 3531835Fields marked by asterisk (*) are required