European Authorized Representative
An E.A.R. serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.
Responsibilities of a European Authorized Representative
- Observe the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the product.
- Ensure the law is met by having Class I medical devices registered with the competent authorities before being placed on the market.
- Ensure their contact information is available to the manufactures to be placed on all the products they are representing, thus acting as a primary contact for the EU Authorities.
- Notify EU Authorities of all major incidents pertaining to products.
- Keep the product’s technical file available at any time for the EU member states authorities and maintain confidentiality with manufacturer's sensitive product information, releasing them only to the appropriate authorities when called upon.
LMG fees for EAR Service is USD 245/Month (per company without limit of products)