Implant Card Requirements of MDR

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Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. The guidance MDCG 2019-8 includes useful hints, which will help the manufacturers during design of an IC. Before diving into details of the requirements, let’s remember definition of an implantable medical device.In accordance with the instructions set out in MDCG 2019-8, the implant card need to also specify a “device type” for the implantable medical device in question. For this, you can check MDCG 2021-11 Guidance on Implant Card to the ‘Device types’.

Implantable Medical Device

Article 2 (5) defines the implantable device as;

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.

The conformity assessment procedures for implantable devices differ from CE marking requirements of a typical medical device

A you know, there are additional requirements for the conformity assessment procedures of implantable devices, which will require attention of the manufacturers during MDR transition. As most of these, requirements listed in Article 18 are not applicable to the sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. So, an implant card is not required for those type of implantable devices. But please bear in mind that the commission has the right to revise this list any time as per Article 115.

Purposes of the Implant Card

As defined on MDCG 2019-8, the purpose of an implant card can be summarized in three bullet points;

  • Enable the patient to identify the implanted devices and to get access to other information related to the implanted device,
  • Enable patients to identify themselves as persons requiring special care in relevant situations e.g. security checks,
  • Enabling e.g. emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations.

Content of the Implant Card

The content of the IC is clearly defined on Article 18 (1). It shall include;

  • Device name,
  • Serial number, lot number,
  • Unique device identification (UDI),
  • Name, address, and the website of manufacturer,
  • Device type (model)

The information listed in paragraph b and d of Article 18 (1) can be part of the instructions for use (IFU) or a leaflet accompanying the implantable device.

According to Article 18 (2), the part of the implant card, which will be given to the patient after implantation shall include blank spaces for;

  • Name of the patient or patient ID,
  • Name and address of the health institution or healthcare provider who performed the implantation,
  • Date of implantation.

These blank spaces shall enable a text at least 2 millimetres high.

Implant Card Technical Requirements

The technical requirements of the implant card can be summarized as follows;

  • Card Dimensions 85.60 mm × 53.98 mm (ISO /IEC 7810 ID-1)
  • Text height at least 2 mm,
  • UDI; AIDC (*) 4 format
  • UDI-DI; HRI (**) 5 format

Similar to IFU and device label, the language of the IC shall be the official language of the member state, where the device has been made available. Since, the proposed size on MDCG 2019-8 is a size of credit card, to overcome the multi-language requirements, use of symbols is encouraged. The use of symbols as per ISO 15223-2 would be a good solution for such problems.

(*) Automatic identification and data capture format (e.g. linear or 2D-Barcodes)

(**) 5 HRI – Human readable interpretation

For further details and questions about the implant card you can contact our experts.