European Authorized Representatives are the legal representative of non-European manufacturers for medical devices sold in Europe. If a company already has offices located in Europe, an Authorized Representative is not needed. However, if you don’t have offices in Europe, you must have a legal agreement with an Authorized Representative that is physically located in Europe to be your primary contact for receipt of customer complaints. The Authorized Representative can also act as your liaison between the Competent Authority in Europe and your company.
The EU Clinical Trial Directive requires every sponsor conducting a clinical trial in the Europe and not having a registered office within the territory of the European Economic Area (EEA) to work with a legal representative who is located in one of the EEA countries. This requirement applies to all clinical trials conducted with medicinal and/or pharmaceutical products as well as medical devices.
Tradefield can be your legal representative in Europe to ensure that your company complies with the above requirements.
A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA. Each and every clinical trial requires a legal representative.
An "Authorized Representative" under the Medical Devices Directives, means:
Any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this directive.
The appointment of an authorized representative does not change the responsibilities of the manufacturer.
Labelling
For Medical Product and in vitro diagnostic medical devices, the label or outer packaging or instructions for use shall contain the name and the address of the authorized representative where the manufacturer does not have a registered place of business in the Community.
The European Representative Role:
Act as your official correspondent for all National Competent Authorities. Submit Notification for your class I medical devices. Where required by national regulation, Register your medical devices with the National Competent Authorities. Provide you with authorization to place our EU Authorised Representative details on your labelling and packaging. Coordinate the communication between you and the National Competent Authorities. Notifies or is notified by the Competent Authorities of serious device incidents or FSCA. Maintain the Technical File of your medical devices to be available for inspection by the European Competent Authorities.
Our range of Representation services:
- Medical Products
- Medical Devices
- Active Implantable Medical Devices
- In Vitro Diagnostics
- Cosmetic Products
- Clinical Studies
