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?
ROLE OF AN EU Authorized RepresentativeWhat is the role of an EU Authorized Representative?
Your European Authorized Representative is responsible for communication and 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 an Incident and Field Safety Corrective Action (FSCA), in collaboration with you and your distributors
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 MDD, IVDD, AIMDD, MDR, IVDR European regulatory affairs and CE Marking.
- Our experienced consultants will evaluate your Technical File, register your medical device or IVD 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.
Please email us if you are looking for a European Authorized Representative.