Implant Card

This is a guide only, and manufacturer and sponsors are encourage to familiarise with article 18 of the Medical Devices Regulation (EU MDR) 2017/745 (MDR).

Implant cards are intended for patients to be able to identify information about devices that is published elsewhere, for example in Eudamed. It is also intended for the patient to identify themselves in case of field safety corrective action (FSCA), security checks or for first responder to be informed about special care/needs for relevant patients.

Information to be provided

The implant card must clearly identify the device and provide any relevant additional information:

• Device name;
• Serial number or lot or batch number;
• Unique device identification (UDI) in human and machine readable format;
• Name, address and the website of manufacturer;
• Website of the manufacturer;
• Device type.

In addition, the patient and the healthcare provider must be identified on the implant card:

• Name of the patient or patient ID;
• Name and address of the healthcare institution which performed the implantation;
• Date of implantation.

Symbols are allowed to convey this data. Some new symbols are introduced:

• Patient name or patient ID.
• Date of implantation.
• Name and address of the implanting healthcare institution/provider.
• Information website for patients.
• Device Name.

The symbol for the device name is particularly interesting. It looks like the medical device’s version of the IVD symbol, but apparently this is not the case.

Use of symbols

Language(s) shall be stated is the determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person.

Implant Card for implantable systems

If an implantable device contains implantable components which might be replaced by other (or the same) components, for example in case of a later revision, the manufacturers should consider the use of a System IC.

For seeking professional advice and comply with these requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) contact us.

Kindly Contact:
MAVEN PROFCON SERVICES LLP.
Address: 1215 & 1216, Iconic Shyamal,
Shyamal Cross Road,
Ahmedabad – 380015, Gujarat, India.
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