CE marking

Three directives the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC), the Medical Devices Directive (MDD)(93/42/EEC) and the In Vitro Devices Directive (IVDD) (98/79/EC), as amended provide the legislative framework within which Member State Competent Authorities and Notified Bodies regulate the so-called European Conformity or Conformité Européenne (CE) marking process.
This is a legally binding statement by the manufacturer that the products being placed on the market meet all the essential requirements as described in the annex of the above mentioned directives. Europe is the second largest medical device market, second only to the US and before countries like Japan, and Australia. This poses attractive opportunities for international companies trying to enter the European market.
However, to be successful, it is essential that companies comply with and are able to meet local requirements and regulations.

Before obtaining a CE mark manufactures must:

• Verify the Essential requirements
• Classify the product
• Choose a conformity assessment route
• Test the device for safety and effectiveness by carrying out appropriate pre-clinical and clinical tests or literature reviews
• Compile a technical file outlining the pre-clinical, clinical and manufacturing steps related to the device
• Implementation and maintenance of ISO 13485 quality systems
• Perform Risk assessment and management -ISO 14971
• Implement a vigilance and Post Market Surveillance(PMS) system
• Have a European Authorised Representative