The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device patient information leaflets. The document outlines the scope of information the leaflets should contain, and also provide additional clarifications regarding the applicable regulatory requirements for various type of documents accompanying medical devices. The guidance describes best practice requirements in the context of information to be communicated by medical device manufacturers in order to ensure the use of a medical device in a safe and efficient manner.
The document published by the TGA also provides recommendations on complying with the applicable regulatory requirements. The present guidance is based on the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002. The authority additionally emphasizes the non-binding nature of the document and the importance of specialized legal advice to be requested by interested parties with regard to compliance with the current requirements. The TGA also reserves the right to amend the document should it be reasonably necessary to reflect the changes to the applicable regulatory framework.
According to the guidance, patient information materials addressed therein are intended to assist patients to:
- Understand the medical device being implanted, both prior to and following surgery;
- Have informed consent conversations with their health professional; and
- Report any adverse events associated with their implanted medical device.
The guidance further describes the regulatory requirements with which leaflets should comply. For instance, it is stated that all information should be provided in English (however, other languages could be used additionally); and could also include schemes or generally acceptable symbols. An implantable or active implantable medical device should be accompanied by the appropriate leaflet, and the information expressed therein should be provided in a way it is clearly understandable for laypersons (patients).
The guidance contains a list of mandatory elements the leaflet should contain, namely:
- Information identifying the device, or the kind of device;
- The intended purpose of the device;
- Information explaining how to use the device safely; and
- Other information about the device that the manufacturer considers would be useful for patients.
The document also provides a table describing the information to be included in a leaflet in detail. According to the table, apart from the elements mentioned above, a leaflet shall also contain information about:
- The way the device should be used;
- Potential side effects that could take place when using the device;
- Residual risks remaining despite the measures taken by the medical device manufacturer to mitigate the risks associated with the device;
- Special measures to be taken by healthcare professionals and patients;
- Risks associated with interactions with other devices;
- Examination and/or maintenance procedures;
- How the incorrect operation of a medical device could be identified;
- Additional measures to be taken in case if the device does not operate as intended;
- Lifetime of the product, as well as the factors impacting it;
- Materials and components of the device;
- Indication that any and all adverse events associated with medical devices and resulting in severe negative consequences should be reported to the Therapeutic Goods Administration as a regulating authority.
According to the present guidance, the information to be provided to patients by virtue of a leaflet should be complete and accurate. The authority additionally emphasizes the importance of completeness of the information to be provided – it is stated that it should be exhaustive as in certain cases, a patient may not have access to other resources to get additional information. It is also important to mention that such statements as “consult your doctor about possible side effects” and “please see the full list of precautions and contradictions in the instructions for use” are explicitly prohibited as they will make it difficult to access vitally important information regarding the device and risks associated thereto.
As mentioned, the information provided in a leaflet should be expressed in a way that is clearly understandable to patients as people having no special qualification and knowledge.
Information About Adverse Events
The TGA also mentions that leaflets shall contain information about undesirable side effects associated with the medical device to which they are related. For certain categories of medical devices (e.g., urogynaecological meshes and breast implants), information about adverse events that have occurred should also be included in leaflets. Such information should be based on data collected by the medical device manufacturer in the course of post-market surveillance activities it should carry out. Consequently, such materials should be subject to periodic review due to the new information obtained.
Providing Leaflets: Suggested Approach
The document further describes the particular way leaflets should be provided by medical device manufacturers. The provisions of existing legislation state that the patient information leaflet should be supplied with an (active) implantable medical device. However, the applicable regulations do not prescribe the particular way it should be done.
According to the guidance, the parties responsible for medical devices shall ensure the leaflet:
- Can be readily accessed by consumers and healthcare professionals;
- Can be accessed free of charge; and
- 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.
Additionally, medical device manufacturers are encouraged to provide leaflets in electronic form (electronic patient information leaflets). Such leaflets could be provided in addition to or instead of basic paper patient information leaflets. At the same time, should the leaflets be provided in electronic form, the manufacturer shall ensure it is easily accessible by patients via the appropriate website. The scope of information to be provided in electronic leaflets should be the same as for ordinary leaflets.
The authority also mentions that if several devices meet specific criteria outlined in the guidance (e.g., manufactured by the same manufacturer and assigned to the same class under the applicable risk-based classification), the manufacturer is allowed to use the same leaflet for all such devices.
In summary, the present TGA guidance provides additional clarifications regarding the applicable regulatory requirements for patient information leaflets. The document outlines the scope of information to be included in leaflets and also highlights the most important aspects to be considered.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.