Medical Devices Directive For Active Implantable Medical Devices, Medical Devices, And In Vitro Diag... Login

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Frequently Asked Questions

• What is an active implantable medical device ?

  Regulations for Active Implantable Medical Devices (AIMD) under the EU Directive 90/385/EEC. An active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes, and which is intended to remain in place.

• Are there any EU directives on medical devices?

  The following medical devices Directives are currently applicable within the EU 1998: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD) 1993: Council Directive 93/42/EEC on Medical Devices (MDD) 1990: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)

• Why is the active implantable medical devices directive important?

  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.

• When do medical devices have to comply with regulation?

  Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

• Is there an EU directive for active implantable medical devices?

  The European Union is currently developing a revised regulation that addresses the requirements for medical devices and active implantable medical devices offered for sale in the EU. Once adopted, the new regulation will replace the EU’s Directive on active implantable medical devices (90/385/EEC) and the EU’s Medical Device Directive (93/42/EEC).

• What is an active implantable medical device ?

  Regulations for Active Implantable Medical Devices (AIMD) under the EU Directive 90/385/EEC. An active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes, and which is intended to remain in place.

• When do implantable medical devices have to be on the market?

  Devices holding a certificate from a European Notified Body under the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfil the specific prerequisite requirements drawn in the MDR.

• What is the reference number for active implantable medical devices?

  The Active Implantable Medical Devices Directive (with the official reference number 90/385/EEC) applies only to active implantable devices.