European Authorized Representative for Medical Device Companies
DUTIES AND OBLIGATIONS
- What are the duties and obligations of an EU Authorized Representative (EC REP)?
- Is it possible for me to appoint a distributor as my representative?
- What do I have to do if I want to change my EC REP?
Interested in finding out more about current CE marking requirements to sell your medical devices in Europe? You need to appoint an EU Authorized Representative (or EC REP), if your company is not domiciled/located in the EU (“non-dom” status). This EC REP will act as your deputy on behalf of your company in dealings with European competent authorities. You must retain an EC REP as long as you sell your devices or performing clinical studies in Europe.
ROLE of an EU Authorized Representative
What is the role of an EU Authorized Representative?
Your European Authorized Representative is responsible for registering your company in the EUDAMED database and communication contact between you and the national competent authorities (Ministries of Health).
Your designated representative will also be responsible for the following:
- Providing assistance with specific device registrations, where necessary
- Provide product identification plus additional information on all European product labels
- Copy the current Technical File or CE Declaration of Conformity to be available for inspection by a Competent Authority, upon request
- Assist with reporting Incidents, Adverse Events and Field Safety Corrective Action (FSCA), in collaboration with you and your distributors
One may also appoint a distributor as your Authorized Representative in Europe. This is however not recommended, as a majority of distributors are not prepared to comply with certain mandatory obligations of an EC REP. Selecting an independent representative to focus on regulatory affairs rather than sales and marketing, is preferable.
A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.
Find out more about the advantages of hiring an independent company to act as your EC REP in Europe.
Why choose VISAMED as your European Authorized Representative?
VISAMED is a highly specialized consulting company providing a full range of services to medical devices companies world-wide. With an experienced and dedicated professional team specialized in medical device regulation, quality systems and product development, VISAMED offers a comprehensive range of services, also acting as European Authorized Representative for Medical Devices Regulation (MDR) (EU 2017/745) and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 European regulatory affairs and CE Marking.
- Our experienced consultants will evaluate your Technical File, register your medical device or In Vitro Diagnostic as necessary, and answer any questions or concerns the competent authorities might have.
- You will be provided with secure online access to all of your documentation and regulatory data, including technical files, labelling information and symbols, language requirements, directives, guidelines, and more.
- Our extensive knowledge about European regulations and the registration of devices will facilitate a smooth and efficient registration process.
- Frequent updates will be provided to all of our Authorized Representation clients, including vital regulatory updates focusing on Europe.
Have you heard about the special packages we offer new European representation clients? Please get in touch with our European Authorized Representative for more information for detailed information about Europe authorized representative services and learn about the process, costs and timelines.
Please email us if you are looking for a European Authorized Representative.