CE marking - achieving compliance with the medical devices directive

From the 14(th) June 1998, it became illegal to place any medical device onto the European Economic Area Market without it having the Communite European (CE) Mark. This legislation was introduced in 1993 as a voluntary code with a five year acclimatisation period. The primary purpose of the Medical Devices Directive (MDD) 93/42/EEC, and the other Council directives covering areas such as toys and safety equipment, is to harmonise technical standards across the European Union. This will enable the free movement of devices within the region whilst still ensuring the safety of these products. The MDD defines three classes of medical devices and these classifications guide the manufacturer along appropriate routes with more stringent procedures being necessary for potentially dangerous equipment. This paper describes the underlying principles of the directive and how a small manufacturing company achieves compliance. The paper also addresses the difficult questions relating to medical products within the EU, and outlines the additional requirements made on a company's quality system and processes. It is considered essential that a sound knowledge base is established to navigate the MDD 93/42EEC.