Placing Medical Devices on the European Union Market

The Global Approach & 'CE' Marking

To support the concept of 'Free Trade' as enshrined in the Treaty of Rome, the European Union has developed the 'Global Approach', which aims to harmonise regulations for a wide variety of products and therefore remove any technical barriers to trade between the Member States.

The 'Global Approach' requires defined products to meet minimum standards of safety and quality (the essential requirements) and then comply with one or more of a selection of conformity routes. Often a third party (Notified Body) is required to intervene and assess the quality management systems of the manufacturer and the product conformity to the essential and other requirements within the Directive. For some product groups a manufacturer's own attestation of conformity is sufficient.

When the requisite process of assessment is satisfactorily completed the 'CE' marking is attached to the product, packaging and instructions and it may then be freely distributed and sold throughout the European Union.

Need more information ?

EU Directive 93/42/EEC - Medical Devices
EU Directive 98/79/EEC - In-Vitro Diagnostic Medical Devices
Copy of the Directive 93/42/EEC
Guidance Notes on the Directives
Listing of Harmonised Standards