From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs) and Patient Implant Cards (PICs), unless specifically excluded from these requirements. PILs and PICs must meet the Essential Principles to be considered compliant.

The guidance provides an overview of:

1. the different types of patient information materials (patient information leaflets and patient implant cards);
2. when patient information must be supplied;
3. how to meet the mandatory requirements for patient information;
4. best practice requirements for patient information; and
5. what to do if your patient information materials are not compliant.
    

Manufacturer and Sponsor Responsibilities

The requirements for patient information materials are part of the essential principles in Part 2 of the MD Regulations. Sponsors must ensure that the kind of device included in the Australian Register of Therapeutic Goods (‘the Register’) under their name complies with the Essential Principles, including the requirements for patient information materials. Manufacturers are responsible for creating the content of the leaflets and cards. Sponsors must ensure that they have available sufficient information to substantiate that the devices comply with the Essential Principles (including the patient information material requirements), or have procedures in place to obtain any relevant information from the manufacturer to substantiate that the materials comply with the requirements in the Essential Principles
 

Leaflets and Cards that are non-compliant with Advertising Legislation

Where the leaflets or cards appear not to comply with the advertising legislation, follow-up actions may be undertaken by the TGA.

Patient Information Leaflets – Mandatory Requirements

A patient information leaflet must be written in English and may also be provided in any other language. It may also include diagrams, drawings or symbols (e.g. MR status symbols). If a patient information leaflet is supplied in hard copy, the leaflet must be written in English, and may also be provided in any other language

1. have text that is legible and at least 1 millimeter high. ‘Text’ includes any: number, letter, symbol, letter or number in a symbol.
2. Applicant must make sure to ensure the leaflet is available and readily accessible by the patient and ensure that the leaflet is written in a way that is readily understood by patients.
    

The leaflet must include:

1. information identifying the device, or the kind of device;
2. the intended purpose of the device;
3. information explaining how to use the device safely: and
4. other information about the device that the manufacturer considers would be useful for patients.
5. in particular, the leaflet must include the information listed in Clause 13A.3 of the MD Regulations.
    

How and when to provide leaflets

Applicant must provide the patient information leaflet to the patient concerned, however, the MD Regulations do not prescribe the manner in which the leaflet must be provided. The TGA expects sponsors and manufacturers to ensure the leaflet:

1. can be readily accessed by consumers and healthcare professionals;
2. can be accessed free of charge; and
3. is available as early as possible, so that medical practitioners and patients can use it to inform their discussions on the proposed course of treatment.
    

Electronic Leaflets

Where leaflets are provided in hard copy, sponsors are strongly encouraged to provide electronic patient information leaflets to enable early access to information for healthcare professionals and patients.
 

When providing electronic leaflets, the applicant has to ensure that:

1. patients are made aware of how to access the electronic versions; and
2. patients can easily navigate the manufacturer’s website and find the correct leaflet.

Sponsors and manufacturers are expected to keep sufficient information to establish that:

1. electronic leaflets have been provided with the device; and
2. the requirements of clause 13A.3 of the MD Regulations have been met.
    

Leaflets for a ‘kind of device’

It is permissible to have one patient information leaflet to cover multiple devices if they meet all of the following criteria. They:

1. are manufactured by the same manufacturer;
2. have the same sponsor;
3. have the same device classification;
4. have the same device nomenclature system code;
5. share the same intended purpose; and
6. share the same warnings, precautions, and user risks.

The leaflet should:

1. clearly identify the devices intended to be covered by the leaflet; and
2. list the name and model of each device.
    

Patient Implant cards

Mandatory requirements: A patient implant card (clause 13A.4 of the MD Regulations):

1. must be available and readily accessible by the patient
2. must be written in English, and may also be provided in any other language;
3. may also include diagrams, drawings or symbols (e.g. MR status symbols); and
4. If a patient implant card is supplied in hard copy, the card must:
   1. have text that is legible and at least 1 millimetre high. ‘Text’ includes any: number, letter, symbol, letter or number in a symbol.

Applicant must include the following information on the card (Clause 13A.2 of the MD Regulations):

1. the name of the device;
2. the model of the device;
3. the batch code, lot number or serial number of the device;
4. the unique device identifier (UDI) of the device (if any); and
5. the manufacturer’s name, address and website address.
    

How to provide implant cards

The patient implant card should be provided to the patient concerned as soon as practical. This will allow health professionals and patients rapid access to the information. Applicant may wish to provide additional space on the card for healthcare professionals to insert:

1. the name of the surgeon; and
2. the name of the hospital where the procedure was undertaken.

Applicant may supply bar codes on stickers with a device as a means of identifying the device. This is acceptable, provided the stickers:

1. are durable; and
2. contain the required information and are in the correct form

In cases where physical patient implant cards containing some of the information and stickers containing the remainder of the required information are both provided with the device, but the sticker is required to be adhered to the card at the point of care, this is considered compliant.
 

Electronic patient implant cards

In addition, or alternatively, to physical cards, you may also provide patient implant cards electronically. However, the card must include all required information (Clause 13A.2 of the MD Regulations). Care must be taken to ensure that electronic patient implant cards are able to be easily accessed by the patient from the provided website and the correct information/card can be found.