The implant card, a new requirement for implantable MDs: are you ready?

Article 18 of Regulation (EU) 2017/745 (MDR) sets out the information to be supplied to the patient with an implanted device and introduces an obligation for manufacturers to provide an implant card.

This card, which includes the patient’s identity, must be provided to each patient with an implant. Healthcare institutions must allow any patient with a device to rapidly access the information contained on the implant card.

The implant card does not cover all implantable devices. Some (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) are exempted.

This card will allow access to a wide range of safety information on the EUDAMED platform via the UDI indicated above. It helps meet the requirements of traceability and informed patient consent laid down in Regulation (EU) 2017/745.

This card must accompany the device throughout the supply chain, through to the end user. It will be linked to the device by a means that ensures that it reaches the end user while controlling the risk of traceability errors (for example, it may be placed in the packaging of the device or in a pouch stuck to the packaging of the device). The healthcare professional may then complete the implant card with the patient’s information in the areas provided for that purpose.

Potential loss of traceability should then be considered. Indeed, this card will be subjected to numerous events likely to reduce the readability of the implant, such as rubbing, exposure to humidity, successive handling, etc. The manufacturer must design and validate the implant card with these events in mind. Moreover, it is essential to ensure that the implant card is intelligible and does not mislead the health professional when they are responsible for completing it. Creating a validation file for the implant card will therefore help validate the characteristics of the card, such as the ageing of the carrier and the likelihood of the card being erased over time, and will also ensure that the spaces made available to health professionals are well defined and thus mitigate the risks associated with its use.

Implementing the implant card involves logistical and technical challenges so that the traceability of information can be guaranteed throughout the life cycle of the implantable medical device.

Why should you turn to the Efor group for assistance?

Our quality and regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics (non-exhaustive list):

• Support in defining the information to be included on the implant card
• Support in developing (technical characteristics, dimensions, etc.) and implementing the implant card
• Support in setting up the validation file for the implant card
• Support relating to the logistical strategy for issuing the implant card
• Support in implementing Article 18 and more specifically in supplying information to the patient with an implanted device

Feel free to contact us using the contact form.