Another important return of Medical Device Regulation (MDR) is the issue of Implant Cards, which are mandatory for Implant manufacturers.

 

The purpose of an Implant Card is to achieve the following three main objectives:

  • The patient can identify the implanted device and access other information about the implanted device (E.g. Through EUDAMED and other websites),
  • To ensure that patients can identify themselves as people who require special treatment in cases such as safety checks,
  • To ensure that emergency personnel or first responders are informed of the specific care/needs for those patients in an emergency situation.

Note: The Implant card must contain sections for information that will be processed by both the manufacturer and the health organization.

 

Information to Be Included on The Implant Card

 

Information to be provided by the manufacturer on the implant card;

  1. Device name,
  2. Device type,
  3. Serial number or lot or party number if available,
  4. Single device ID (UDI); UDI-DI as AIDC4 format and UDI-DI as HRI5,
  5. The name and address of the manufacturer of the medical device,
  6. Medical device manufacturer’s website.

 

Note: Any information, such as warnings, precautions, or measures, that may be taken by the patient or a healthcare professional in the web site, in accordance with the logically predictable external effects, medical examinations, or interacting (reciprocal) with environmental conditions, must be included.

 

Information to be provided by the Health Organization on the implant card;

  1. Patient name or patient ID,
  2. The name and address of the health organization that performed the implantation,
  3. Date of implantation.

 

Products exempt from the implant card;

  • Sutures (surgical yarns),
  • Staples,
  • Dental fillings,
  • Dental brackets,
  • Dental Crowns,
  • Screws,
  • Keys,
  • Plates,
  • Wires,
  • Pins,
  • Clips and Connectors.

 

See. References

  • MDCG 2021-11 Guidance on Implant Card – Device types
  • MDCG 2019-8 v2 Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

The Medical Devices Regulation (MDR) EU 2017/745