Active Implantable Medical Devices Directive
Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)
The Active Implantable Medical Devices Directive (with the official reference number 90/385/EEC) applies only to active implantable devices. For a device to be classified as an ‘active implant’, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure.
The Active Implantable Medical Devices Directive has a a first objective the harmonisation of the regulatory environment across the European Economic Area, and at the same time, it enables the free movement of goods within the European Union.
The Directive sets out the essential safety requirements in terms of function, sterility, material compatibility, marking, ‘user’ instructions, design documentation and CE marking but also include requirements for type approval, production quality management, clinical investigation and manufacturer registration.
Which Products Are Covered By The Active Implantable Medical Devices Directive?
The Active Implantable Medical Devices Directive (90/385/EEC) covers medical devices that match the definition provided in the directive:
Which Products Are Not Covered By The
Active Implantable Medical Devices Directive?
Excluded from the Active Implantable Medical Devices Directive are:
How to Comply with the Active Implantable Medical Devices Directive:
For all active implantable medical devices, the involvement of a Notified Body is obligatory.
European Harmonised Standards Related to Active Implantable Medical Devices Directive:
The Latest Related Blog Posts About the Active Implantable Medical Devices Directive:
Report on Failing Active Implantable Medical DevicesNovember 26, 2018
European Commission Publishes Updated Borderline & Classification ManualNovember 15, 2018
French Notified Body Initiates Product Recall for Breast ImplantsMarch 5, 2014
Notified Bodies ExplainedNovember 21, 2013
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