CE Mark

Medical Device Regulatory Advisors, Inc. (MDRA) can assist your company with the following:

• International Regulatory Strategic Plans
• Product Classification Determination Assistance
• Pre-assessment and Gap Analysis Audits
• Preparation of Declarations of Conformity
• Preparation of Essential Requirements
• Preparation of Technical Files
• Translation Services

A CE Mark is a European marking of conformity that indicates that a product is in compliance with the requirements of European laws or Directives in the areas of safety, health, environment and consumer protection.

CE marking gives a company easier access to the European market to import their product without adaptation or rechecking.

The CE Mark is required in the 18 countries of the European Economic Area (EEA).

If the manufacturer is exporting to a country within the European Economic Area (EEA) and a device that been awarded the "CE Mark", the FDA will accept documentation of the "CE Mark" in lieu of a letter from the foreign government approving importation.