An E.A.R. observes the manufacturer’s compliance with the conformity assessment procedure set out in the European directives which apply to the product.
We ensure the law is met by having Class I medical devices registered with the competent authorities before being placed on the market.
We 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.
We must notify EU Authorities of all major incidents pertaining to products.
An E.A.R. must understand all EU regulations from each of the EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.
We must 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.
MED DEVICES LIFESCIENCES LIMITED was formed to provide medical device manufacturers world-wide with flexible and well adjusted service packages to assist its clients to comply with EU & US legislation .
Med Devices 123 fifth Avenue New York, NY 10160 Ph: +19142942185 Email: firstname.lastname@example.org