AIMDD — Active Implantable Medical Devices Directive 90/385/EEC

The directive that governed active implantable devices such as pacemakers and implantable defibrillators before the MDR, repealed by the MDR subject to transitional provisions.

Reference: MDR Article 122

Implantable device

Any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

Reference: MDR Article 2(5)

Implant card

The card supplied with an implantable device carrying the information needed to identify it, including name, serial or lot number and UDI, together with warnings and precautions. The health institution makes it available to the patient.

Reference: MDR Article 18