Regulation EU 2017/745 introduced a new requirement for the manufacturer of implantable medical device. 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 but also to enable emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations. Medical devices such as staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors are exempted from these obligations.
Article 18 of the Regulation describes the main information to be reported on the IC:
- device name, serial number, lot number, the UDI, the device model, the name and the address of the manufacturer;
- warnings, precautions or measures to be taken by the patient or a healthcare professional about reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
- information about the expected lifetime of the device and any necessary follow-up
Article 18, lays down that Member States shall require health institutions (or healthcare providers) inter alia to make available the IC to the relevant patient. The IC should bear their identity. For this purpose, the IC provided together with the device should contain blank fields which shall be filled out by the health institution or healthcare provider, respectively.
Considering the high impact of Article 18 requirements, in particular as concerns the aspect related to the information to be provided by health institution or healthcare provider, that may have a great impact from the economic and logistic stand point, a specific guidance document has been issued on June 2019 by the Medical Device Coordination Group (MDCG) (MDCG 2019-8 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 guidance document defines the fields to be completed by the implanting healthcare institutions or healthcare providers, that is:
- Name of the patient or patient ID;
- Name and address of the health institution or healthcare provider who performed the implantation;
- Date of implantation.
This means that in the development of the IC the manufacturer must foresee blank fields for this information. Furthermore, the guideline reports a list of symbols that may be used in the implant cards as well as designs examples of Implant Cards.
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