The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the industry representatives on the application of the Article 18 of the Medical Device Regulation 2017/745 (MDR). In particular, the document highlights the information to be included by the manufacturer of the device to the Implant Card and provides additional recommendations regarding filling the IC.
Implant Card: A Brief Overview
The Implant Card has been introduced to:
- Provide the patient with the information regarding the implanted device, allowing to use identification details to obtain additional information using the databases (including the EUDAMED database expected to be launched),
- Provide patients with the possibility to inform others that they require special care (for example, during the security checks),
- Provide healthcare professionals with the information necessary to be considered in emergency situations.
General requirements applicable to the Implant Card are set forth in the Medical Devices Regulation 2017/745. In particular, Article 18 of the aforementioned regulation describes in detail the requirements the manufacturer of the device shall fulfill when providing the Implant Card that should accompany the device when being supplied. According to these requirements, the scope of the information provided by the manufacturer should cover the following core points:
- Name of the device,
- Lot number and serial number,
- Unique Device Identification (UDI),
- Information about the manufacturer, including the name, address and the website,
- Indication of the type of the device.
According to the applicable regulation, the patient should be provided with the Implant Card containing his identity. All Implant Cards supplied with the devices should contain blank fields to be used by healthcare professionals to fill in the appropriate information regarding the patient. The MDCG emphasizes that it is necessary to ensure that despite all country-specific aspects, all Implant Cards provided to the patients contain the fields for the main information about the patient, namely,
- Name of the patient,
- Information about the institution (including the name and address) that conducted the appropriate procedure,
- Indication of a date when the implantation has been performed.
Information to be Included in an Implant Card
The guidance issued by the MDCG describes in detail the information to be provided by the manufacturer of the device, and also the information to be provided by the healthcare institution.
In particular, the manufacturer shall indicate:
- Name of the device,
- Type of the device,
- The serial number of the device itself, and also a lot (batch) number,
- UDI,
- Information about the manufacturer, including its name and address,
- Link to the website of the manufacturer.
The guidance document also provides the requirements applicable to the form the text should be presented: the text (e.g. numbers, letters or symbols) should be at least 2 millimeters high to be easily readable.
As was mentioned before, the IC provided by the manufacturer together with the device should contain the appropriate blank fields for the information to be added by the healthcare institution performing the implantation procedure. The information to be filled in by the institution includes the details about the patient, the institution itself and also the indication of the date the device has been implanted.
Implant Card: Additional Requirements
The guidance document also provides information regarding the additional requirements to be taken into consideration in relation to the Implant Cards, namely:
- It is recommended to use symbols to reduce discrepancies related to the national specifics. The guidance contains the list of symbols to be used to indicate the name of the patient, healthcare institution and the manufacturer, the website, and also the information about the device including its name, serial and lot numbers, and the UDI. These symbols comply with the ones provided by the applicable ISO standards. All information should be filled in using the language determined by the appropriate Member State. The MDCG additionally emphasizes that since there is no special symbol to indicate the type of the device, this information should be also provided in the language acceptable by the Member States. At the same time, the previously printed information could be provided in several languages allowing the healthcare institution to choose one.
- It is also necessary to accompany the Implant Card with the additional instructions on filling it in. Such instructions should also include the explanations of the symbols used. This information could be provided in the form of a leaflet supplied with the device and IC, printed in the languages used in the appropriate Member State. The manufacturer shall assess the legibility and usability of the information provided and ensure that it covers all important aspects the institution filling in the form should be aware of.
- In the case of implantable systems, the manufacturer shall provide a special System IC containing the information about the components that could be replaced. In this case, it is also necessary to highlight the ways healthcare professionals using the System IC could ensure it is filled in properly and contains up-to-date information.
The guidance also provides examples of the designs that could be used to develop Implant Cards and leaflets accompanying them. It is also mentioned that the Implant Cards shall comply with the requirements set forth by the ISO/IEC 7810 ID-1 in the means of basic shape (it should be the same as for credit cards).
The examples provided include general Implant Cards, System IC, the leaflets with the instructions describing the way the IC should be filled in properly, and also the stickers provided with the IC to indicate the particular type of the implantable device (the Implant Card shall contain the appropriate blank space for placing such stickers).
General implant card:
The example demonstrates the way symbols should be used to indicate the type of information to be provided in the appropriate fields, while the text in green provides the example of handwritten text to be filled by the healthcare professional.
The rear side of the IC – The rear side of the IC should contain information about the device itself and its manufacturer.
The example of the System IC – In the case of a System IC, it should contain several blocks with information regarding the device describing each component of the system.
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Sources:
https://ec.europa.eu/docsroom/documents/40321?locale=en
