Active Medical Devices

Active Medical Devices BSIA manufacturer who wishes to sell medical devices on the EU market must meet the regulations of the Medical Device Directive (93/42/EEC). The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC.

As a Notified Body under the Medical Devices Directives, we have one of the broadest scopes of any Notified Body.