NHS Innovations North
Regulations
As one of the countries in the European Economic Area (EEA) product groupings are required to be CE marked. CE marking is required to show a product conforms to its relevant European Directive.
For medical products, CE Marking is required only for the following types of products: medical devices (EU directive 93/42/EEC), Active Implantible Medical Devices (EU Directive 90/385/EEC) and in vitro diagnostic devices (EU Directive 98/79/EC). CE Marking is not required for chemicals, pharmaceuticals, cosmetics and foodstuffs.
The UK is one of the countries in the European Economic Area (EEA) and as such certain product groupings that are sold are required to be CE marked. CE marking is required to show a product conforms to its relevant European Directive.
For medical products, CE Marking is required only for the following types of products: medical devices (EU directive 93/42/EEC), Active Implantible Medical Devices (EU Directive 90/385/EEC) and in vitro diagnostic devices (EU Directive 98/79/EC). CE Marking is not required for chemicals, pharmaceuticals, cosmetics and foodstuffs.
The European directives provide a framework for controlling medical devices for public safety and effectiveness while allowing free trade between EU member states. The directives apply to medical devices and their accessories, for example, under MDD 93/42/EEC devices included are systems, accessories to medical devices, custom made devices and devices for clinical investigations.
The directives set essential requirements to allow the above aims to be met, namely:
- general requirements
- requirements regarding design and construction
- requirements regarding the information the manufacturer needs to supply with the device
Each directive has a system that classifies each device according to its level of risk. It defines procedures that a manufacturer must implement before "CE marking" is allowed.