Implant Card: Regulatory Requirements and Manufacturer Obligations

“The implant card is not just a regulatory obligation: it is a key tool to ensure the safety and traceability of implantable devices.”

Introduction

Since the entry into application of Regulation (EU) 2017/745 on medical devices (MDR), manufacturers of implantable medical devices have been subject to specific requirements concerning the implant card, as set out in Article 18.

This obligation aims to strengthen the traceability of implanted devices and to ensure that patients have access to essential information relating to their implant.

Why an Implant Card?

Article 18 of Regulation (EU) 2017/745 requires that all implantable medical devices be accompanied by an implant card provided to the patient after the procedure.

The following devices are excluded: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

This requirement is intended to:

• Ensure clear and reliable identification of the implanted device;
• Facilitate traceability in the event of an incident, field safety corrective action, or product recall;
• Enable rapid access to essential information in emergency situations;
• Enhance transparency and patient autonomy.

What must the Implant Card contain?

In accordance with Article 18 of Regulation (EU) 2017/745, the implant card must enable identification of both the device and the manufacturer.

Information under the Manufacturer’s Responsibility

At a minimum, the implant card must include:

• Device name;
• Model or device type;
• Serial number or, where applicable, batch number;
• Unique Device Identifier (UDI);
• UDI in human-readable format and in AIDC format (barcode or DataMatrix);
• Name and address of the manufacturer;
• Manufacturer’s website.

Information to be completed After implantation

The implant card must also include blank fields to record:

• Patient name or identifier;
• Name and address of the healthcare institution or healthcare professional who performed the implantation;
• Date of implantation.

The information provided by the manufacturer must be drafted in the language(s) required by the Member State in which the device is made available.

Format: What does the MDCG recommend?

The MDCG 2019-8 guidance document issued by the Medical Device Coordination Group provides practical recommendations regarding the presentation of the implant card.

It recommends:

• An ID-1 format (equivalent to a bank card size), in accordance with ISO/IEC 7810 ID-1;
• Clearly legible text, with a minimum character height of 2 mm;
• A durable and long-lasting material;
• A harmonized structure at European level;
• The provision of an explanatory leaflet describing the symbols used and the information to be completed on the implant card.

How to ensure proper use of the Implant Card

The implant card should not be considered merely an informational support. It is subject to the risk management and usability engineering processes.

In this context, the manufacturer must:

• Assess the risks associated with misinterpretation or incorrect completion of the card;
• Verify, through usability testing, that the instructions provided enable healthcare professionals to correctly complete the required information;
• Integrate these elements into the technical documentation and the risk management file in accordance with MDR requirements.

The usability evaluation must therefore demonstrate that the implant card can be correctly completed and used without generating errors that could affect traceability or patient safety.

Conclusion

The implant card constitutes a major regulatory obligation for manufacturers of implantable medical devices under Regulation (EU) 2017/745.

However, beyond the formal requirement, it represents a key tool for traceability, incident management, and patient safety.

Compliance requires:

• Precise regulatory content;
• A standardized and durable format;
• Integration into risk management and usability evaluation processes;
• Adaptation to national linguistic requirements.

The implant card therefore fully aligns with the MDR’s objective: strengthening transparency, improving traceability, and ensuring a high level of protection of patient health.

Is your Implant Card fully compliant with Article 18 of the MDR?

At Certeafiles, we support you:

• Personalized support by our experts
• Adapted practical training
• Internal audits

👉 Contact us for a free initial consultation and discover how Certeafiles can accelerate your UE process.