Process of EAR Appointment
Are you Medical Device Manufacturer from a Non European Country? If your answer is yes, you need to appoint European Authorized Representative EAR / EC REP
Planning for CE Marking Certification from a Notified Body for a company does not have a physical location in the EU, you are required to appoint an Authorized EU Representative, also referred to as an EC REP, to represent your company to European authorities. Your devices sold in European Region must have a EC REP logo, Name and complete adress with contact Information as long as you sell your devices in Europe.What are the duties of an European Authorized Representative (EAR) or EU Representative Service?
The role of a European Authorized Representative are those include, but are not limited to, the following:
- Providing a registered address within the European Union
- Keeping all technical documentation available for inspection by the European Authorities
- Preparing notifications to European Regulatory Authorities
- Submitting registrations to national databases
- Action plan for incident reports if any
- Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
© Copyright 2017 QualiMEDtech.