The Regulation (EU) 2017/745 introduced an additional obligation for implantable medical devices, the implant card. It achieves two specific objectives: to increase transparency and to ensure better access to information about the IMD.
IMD manufacturers will have to indicate all the required information on an implant card that will be delivered with the device. In addition to the blank fields intended to be filled in by the health establishment implanting the device, the following information will be indicated:
- The name of the medical device
- The type of device
- Serial number, batch number
- The name and contact information of the manufacturer
- The url address of the manufacturer’s website
The last information indicated on the implant card is the unique device identifier (UDI) in the form of a barcode, as well as the “device” identifier (UDI-DI), which must absolutely be readable by humans. The information linked to the identifiers is of crucial importance for the traceability of DM. Since it must be accessible at any time, it is important to use a high-performance software platform to manage this information.
Implant cards are no bigger than a credit card. They must therefore meet precise criteria to ensure that they can be read correctly by end users. They are accompanied by a booklet containing all the instructions for filling in the card correctly as well as the legend of the symbols used. These are recommended to avoid multiple versions. As for the characters, their height must be at least 2 millimeters, whether they are letters, numbers or symbols.
Information for patients are also provided. This includes warnings and precautions, information on the lifetime of the device and possible follow-up, or information to ensure a safe use of the medical device by the patient.
When necessary, the implant cards will need to be updated. Thus, by connecting to the European database Eudamed or to the manufacturer’s website, the patient will be able to easily identify the device and will have access to safety information.
Find all the information related to the new medical device regulations on the European Commission website.
Do the implant cards apply to medical devices already on the market?
No, the cards only apply to medical devices placed on the market under Regulation (EU) 2017/745
Does the implant card have to include both the UDI-DI and UDI-PI?
Yes, it is a requirement! Both pieces of information must be included on the implant card.
Does the implant card cover all implantable medical devices?
No. Sutures, staples, dental fillings, orthodontic appliances, dental crowns, screws, wedges, plates, guides, pins, clips, connecting devices are exempt.