The European Medical Device Directives
The core legal framework for medical devices in the EU consists of three directives:
- Directive 90/385/EEC regarding active implantable medical devices (AIMD)
- Directive 93/42/EEC regarding medical devices (MDD)
- Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD)
All medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.
BSI is a full scope Notified Body to the Medical Device Directives. This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is a legal requirement, BSI has the technical expertise to provide appropriate conformity assessment services.