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Medical Device Patient Information Leaflets and Implant Cards

  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.
  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.
  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.
  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.
  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.
  1. electronic leaflets have been provided with the device; and
  2. the requirements of clause 13A.3 of the MD Regulations have been met.
  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.
  1. clearly identify the devices intended to be covered by the leaflet; and
  2. list the name and model of each device.
  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.
  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.
  1. the name of the surgeon; and
  2. the name of the hospital where the procedure was undertaken.
  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.