This is a guide only, and manufacturer and sponsors are encourage to familiarise with article 18 of the Medical Devices Regulation (EU MDR) 2017/745 (MDR).
Implant cards are intended for patients to be able to identify information about devices that is published elsewhere, for example in Eudamed. It is also intended for the patient to identify themselves in case of field safety corrective action (FSCA), security checks or for first responder to be informed about special care/needs for relevant patients.
Why is an Implant Card Important for Patient Safety?
An implant card plays a crucial role in ensuring patient safety by providing essential information about an implanted medical device. Under the Medical Devices Regulation (EU) 2017/745 (MDR), manufacturers are required to provide implant cards to patients, enabling them to identify their device and access important details when needed.
One of the primary benefits of an implant card is that it helps patients and healthcare professionals quickly retrieve information about the device in case of medical emergencies. First responders and medical personnel can refer to the card to understand any special care requirements, reducing the risk of complications during treatment.
Additionally, in the event of a Field Safety Corrective Action (FSCA) or a product recall, the implant card helps manufacturers and regulatory bodies efficiently trace affected patients, ensuring that necessary corrective actions are taken without delay. The inclusion of Unique Device Identification (UDI) further enhances traceability and patient protection.
For patients traveling through security checks (such as in airports), an implant card can serve as proof of their implanted device, preventing unnecessary delays or inconvenience. Furthermore, having access to the manufacturer’s website allows patients to stay informed about any updates, safety notices, or maintenance requirements related to their device.
By standardizing symbols and language, implant cards ensure that patients across different regions can understand the information easily. Ultimately, implant cards empower patients with knowledge about their medical devices, enhancing safety, transparency, and trust in healthcare systems.
Regulatory Requirements for Implant Cards Under EU MDR 2017/745
The Medical Devices Regulation (EU) 2017/745 (MDR) requires manufacturers to provide implant cards for implantable medical devices. These cards ensure that patients, healthcare providers, and regulatory bodies can access essential device information.
Purpose of Implant Cards
Implant cards serve multiple functions, including:
- Helping patients and healthcare providers identify the implanted device.
- Supporting field safety corrective actions (FSCA) if necessary.
- Assisting first responders in providing appropriate medical care.
- Enabling patients to provide device details during security checks or medical emergencies.
Mandatory Information on Implant Cards
According to Article 18 of EU MDR 2017/745, an implant card must include:
- Device Identification: Device name, serial/lot number, Unique Device Identification (UDI) in human and machine-readable formats.
- Manufacturer Details: Name, address, website of the manufacturer.
- Healthcare Provider & Patient Information: Name/ID of the patient, implanting healthcare institution, and implantation date.
Use of Symbols and Language
To ensure clarity, symbols are allowed for conveying information such as patient name, implantation date, and manufacturer details. Additionally, the language must be understandable by a layperson and comply with national requirements.
Compliance and Professional Guidance
Manufacturers must ensure that implant cards meet EU MDR requirements. For expert guidance on compliance, manufacturers and sponsors should seek regulatory consultation to avoid non-compliance risks.
Who Needs an Implant Card?
An implant card is essential for patients who have received an implantable medical device under the Medical Devices Regulation (EU) 2017/745 (MDR). These cards help patients and healthcare providers track important device details, ensuring safety, proper identification, and post-implantation care.
Who Requires an Implant Card?
- Patients with Permanent Implants: Individuals with devices like pacemakers, artificial joints, cochlear implants, or heart valves need an implant card to keep a record of their device information.
- Patients at Risk of Recalls or Replacements: If an implantable device is subject to a Field Safety Corrective Action (FSCA), the implant card helps in identifying affected patients quickly.
- Patients Undergoing Security Checks: Some implants may trigger metal detectors at airports or security points. The card serves as proof of the medical device’s presence.
- Emergency Medical Situations: First responders and healthcare professionals can access crucial device information from the card to provide appropriate medical care.
- Patients Requiring Future Surgeries or Adjustments: Some implants have components that may need revision or replacement over time. The implant card ensures correct device tracking.
What Information is Included?
An implant card contains key details such as the device name, serial or batch number, UDI (Unique Device Identification), manufacturer details, and implantation date. It also includes patient and healthcare provider details to facilitate follow-ups.
For guidance on compliance with EU MDR Article 18 and implant card requirements, manufacturers and sponsors should seek professional consultation.
Information to be provided
The implant card must clearly identify the device and provide any relevant additional information:
- Device name;
- Serial number or lot or batch number;
- Unique device identification (UDI) in human and machine readable format;
- Name, address and the website of manufacturer;
- Website of the manufacturer;
- Device type.
In addition, the patient and the healthcare provider must be identified on the implant card:
- Name of the patient or patient ID;
- Name and address of the healthcare institution which performed the implantation;
- Date of implantation.
Symbols are allowed to convey this data. Some new symbols are introduced:
- Patient name or patient ID.
- Date of implantation.
- Name and address of the implanting healthcare institution/provider.
- Information website for patients.
- Device Name.
The symbol for the device name is particularly interesting. It looks like the medical device’s version of the IVD symbol, but apparently this is not the case.
Use of symbols
Language(s) shall be stated is the determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person.
Implant Card for implantable systems
If an implantable device contains implantable components which might be replaced by other (or the same) components, for example in case of a later revision, the manufacturers should consider the use of a System IC.
For seeking professional advice and comply with these requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) contact us.
