​​An implant card is given to patients who have received a permanently implantable medical device or an active implantable medical device. Manufacturers of implantable devices are responsible for creating an implant card that contains information about the implanted device.

The purpose of implant cards is to enable the patient to identify the implanted device and access other information related to it as well as to inform healthcare professionals and others of the need for special treatment these patients may have in emergency situations.

For special implant card requirements and information to be supplied to patients with implants, see MDR Article 18. The manufacturer shall provide an implant card together with implantable medical devices. The card identifies the device and contains necessary warnings / precautions such as the expected lifetime of the device. 

The manufacturer of the implantable medical device must disclose the following information with the device: 

  • ​Identification of the device
    • ​device name
    • serial number
    • lot number
    • UDI
    • device model
    • manufacturer’s name, address and website

  • ​necessary warnings/precautions that the patient or healthcare professionals must take into account for example
    • ​interference
    • external influences
    • environmental conditions

  • information about the expected lifetime of the device and any necessary follow-up

  • any other information to ensure safe use of the device by the patient

The information must be made available to the patient rapidly and easily. Updates must be made available via the manufacturer's website. The information must be in Norwegian.

The Norwegian Medicines Agency requests health institutions to give patients with implant cards rapid access to current information about their implanted medical device.

For certain implants, exceptions have been made from the implant card requirement and information provided to patients, see MDR article 18 (3).

For further information see Factsheet for Manufacturers of Implantable Medical Devices.

Publisert: 20.04.2022

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