Implant Card: New Production and Printing Service

To meet the needs of implantable medical device manufacturers, we offer a complete solution for the production and printing of implant cards.

Article 18 of Regulation (EU) 2017/745 requires manufacturers to provide the necessary information for the unique identification of the implanted device on an implant card delivered with the device.

The implant card must include a fillable space for the healthcare professional to enter the patient’s data and a series of spaces for affixing dedicated labels – also provided by the manufacturer and applied by the doctor – that identify the implanted medical devices.

Implant Card

Our implant card, compliant with applicable technical standards, is made of 250 g/m² cardstock and consists of 8 pages. The folded dimensions – as standardized – are 80x50mm so that the patient can carry it in their wallet.

The first and last pages are provided pre-printed: the first displays symbols and spaces for the doctor to enter the patient data by hand; the last is customizable with the manufacturer’s graphics and contact information.
The other 6 (two on the front and 4 on the back) are intended to accommodate the labels of the implanted medical devices and allow manufacturers whose implants consist of multiple medical devices to include the maximum number of labels on a single card.

Printing System for Implant Card Labels

The labels to be affixed to the implant card, containing the data of the implanted devices, must also be provided by the manufacturer.

To address this need, we can provide the printing system for implant card labels, consisting of:

• Thermal printer and labels of appropriate size to be affixed to our implant card;
• The graphic design of the labels, developed by us in compliance with applicable regulations;
• The printing software capable of generating the UDI vector and, in the advanced version, able to interface with existing databases at the manufacturer’s site to automatically obtain medical device data, in order to automate the process.

The printing system, as provided, ensures successful results in mandatory tests for indelibility, legibility, and UDI vector readability.

Comprehensive Consultation and Customization

We support implantable medical device manufacturers in the CE marking process, which is why the production and supply service of the implant card printing system is accompanied by direct assistance regarding compliance with applicable mandatory requirements.

Additionally – within the limits allowed by applicable regulations – the implant card and related labels can be customized to meet the needs of each individual manufacturer.