Standards Used in the Regulation of Medical Device in EU

Medical devices standards system in EU is composed of directive,harmonized standards and conformity assessment procedures. The directive rules essential requirements to products and describes the methods,by which conformity with these requirements can be demonstrated.The harmonized standard is a technical specification with the purpose of supporting the essential requirements of the directive. The conformity assessment procedures are used to demonstrate if the devices meet the essential requirements.Production with CE mark can be sold freely in EU market.This article introduced the medical devices standards system in EU from the directive,harmonized standards and conformity assessment procedures.