Update on Implant Card Requirements
Recently, the TGA and European Medical Device Coordination Group (MDCG) released guidance on implant cards and patient leaflet requirements in their respective jurisdictions.
[MDCG Guidance | TGA Guidance | TGA Best Practice]
This provides a great opportunity to review similarities and differences in the implementation of patient implant cards in regions.
What is an Implant card?
A patient implant card is a small, portable card intended to be provided to patients following surgery who have received either a permanent implantable medical device or an active implantable medical device.
Both European and Australian Regulations now define requirements for implant cards for all implantable devices. The regulations also include a range of devices that are exempt from the implant card requirements such as screws, sutures, staples, etc.
Key contents to be displayed on implant cards are similar across regions and include:
- name of the device;
- model of the device;
- batch code, lot number or serial number of the device;
- unique device identifier of the device (if any)
- manufacturer’s name, address and website
In Europe, additional information is required to be supplied by the health care institution on the implant card, as follows:
- Name of the patient or patient ID;
- Name and address of the healthcare institution which performed the implantation;
- Date of implantation.
In Australia, whilst this additional information is not specifically required on the implant card, a patient leaflet is needed. The patient leaflet includes similar information for the patient, including but not limited to the name of the device, warnings, special instructions and a notice to report any serious incidents to the manufacturer and TGA.
Prominence of warning statements shall be consistent with the device risk management activities (refer ISO 14971). Whilst there is no direct requirement to include warnings on the patient implant card, manufacturers may include some warnings directly on the device implant card where appropriate (e.g. warnings about possible interactions with other electronic equipment such as airport security scanners or magnetic resonance imaging (MRI) equipment for pacemakers or intra-ocular lenses).
Regardless of their inclusion on the implant card itself, the (Australian) regulations mandate to include warnings and risks associated with the device, in the patient information leaflet.
The patient implant card is typically provided as a physical card, the size of standard business card or bank card which the patients can handover to a health professional for quick access to certain information about their implant. It consists of fixed fields and variable fields that mostly reflect traceability elements of the final device implanted.
The MDCG Guidance and the TGA Guidance and TGA Best Practice provide great examples of presentation, including guidance on the use of symbols.
The Regulators also warn manufacturers that leaflets and implant cards are not intended to be promotional materials. Manufacturers and Sponsors must ensure they do not present the information in a way that could be considered promotional or in breach of the advertising code.
Timing for implementation
Implant card and patient leaflet requirements are already implemented for new devices in Australia and non-exempted devices must be accompanied by both implant cards and patient leaflets. Existing devices (i.e. released prior to release of the ruling) are still under a grace period for implementation until 1st December 2021.
In Europe, whilst implementation is immediately encouraged to facilitate transition, enforcement of the requirements will essentially coincide with the MDR enforcement deadline, due May 2020.
If you have any questions about implant cards and/or patient leaflets in either Australia or Europe, be sure to reach out to Brandwood CKC for a no obligation discussion.
We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)