The implant card is one of the new requirements of the European Medical Devices Regulation (MDR) EU 2017/745.
The manufacturers of implantable devices must prepare and provide to the patients an implant card (IC) containing some information on the implanted device. The aim of the IC is to enable the patient to identify the implanted devices and to get access to other information related to it.
Implant cards also enable emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations.
Considering the strict requirements of MDR Article 18, manufacturers are presently facing a great impact from the economic and logistic standpoint. A specific guidance document has been issued on June 2019 by the Medical Device Coordination Group (MDCG): MDCG 2019-8.
This training course aims to equip medical device professionals realise what the MDR Art. 18 impact is and how to implement compliant implant cards accordingly.