Implant Card2024-12-04T01:58:25+03:00

Another important provision of the Medical Device Regulation (MDR) is the mandatory Implant Cards for Implant Manufacturers.

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

  1. To enable the patient to identify the implanted device and access other related information about the implanted device (e.g., through EUDAMED and other websites),
  2. To allow patients to identify themselves as individuals requiring special treatment during situations such as safety checks,
  3. In emergencies, to ensure that emergency service personnel or the first responder is informed about the special care/needs for the patients in question.

Note: The Implant Card should contain sections for both the manufacturer and the healthcare provider.

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, if applicable, lot or batch number,
  4. Unique Device Identifier (UDI); UDI in AIDC4 format and UDI-DI as HRI5,
  5. Name and address of the medical device manufacturer,
  6. Website of the medical device manufacturer.

Note: The website should include information regarding any warnings, measures, or precautions related to foreseeable external effects, medical examinations, or reciprocal interactions with environmental conditions that may be taken by the patient or a healthcare professional within the logical framework.

Information to be Provided by the Healthcare Provider on the Implant Card:

  1. Patient’s name or patient identification,
  2. Name and address of the healthcare facility that performed the implantation,
  3. Date of implantation.

Products Exempt from Implant Card Requirement:

  1. Sutures (Surgical Threads),
  2. Staple wires,
  3. Dental fillings,
  4. Dental brackets,
  5. Dental crowns,
  6. Screws,
  7. Wedges,
  8. Plates,
  9. Wires,
  10. Pins,
  11. Clips, and connectors.

See References

  • MDCG 2021-11 Implant Card Guide – “Device Types”
  • MDCG 2019-8 v2 Implant Card Regarding the Application of Article 18 of the European Parliament and Council Regulation (EU) 2017/745 of 5 April 2017 on Medical Devices
  • Medical Device Regulation (MDR) 2017/745/EU
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