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.
The implant card must clearly identify the device and provide any relevant additional information:
In addition, the patient and the healthcare provider must be identified on the implant card:
Symbols are allowed to convey this data. Some new symbols are introduced:
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.
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.
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.
MAVEN PROFCON SERVICES LLP.
Address: 1215 & 1216, Iconic Shyamal,
Shyamal Cross Road,
Ahmedabad – 380015, Gujarat, India.
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