General Statement and aim of the EBCP CE-Product Complaint SupportActivity

General Statement:

Since June 1998, CE Marking is a legal requirement stating that certain medical products sold to the countries of the European Union (EU) must be approved by a notified body indicating that they have met the essential requirements set out by the Medical Device Directives (MDD).

Although these requirements are six years ago, very little is known by the medical community regarding the steps in reporting product deficiencies and subsequent accidents.

The Aim of EBCP Support:

The EBCP is committed to providing assistance in this process by providing a central contact point through which questions may be directed regarding the steps involved in filing a product complaint and the contact numbers needed in reporting a product deficiency.

The EBCP intent is to improve patient safety through enhancing the initiation of a product complaint process and promoting the reporting of product deficiencies and any accidents related to a product by perfusionists.

Limits of the EBCP Role in Individual Product Complaint Processes

REPORTING OF CASES is a vital aspect of device regulation. Documenting strengths and weaknesses of devices after the product has been in clinical use for a number of years is the only way to maintain quality control, for it is only then that technical problems become apparent.

Responsible health care providers in the EU should report problems to the manufacturers and regulatory authorities so that hazards can be promptly identified. ________________

EBCP Assistance

The EBCP will help in this process by:

1) providing contact information and clarifying the possibilities an

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