The present article describes in detail the regulatory approach to be applied concerning clinical evidence related to custom-made medical devices and also highlights certain other aspects related to clinical evidence submitted in the context of applying for marketing approval for patient-matched, adjustable, and custom-made medical devices. 

The Therapeutic Goods Administration (TGA), an Australian regulating authority responsible for healthcare products, has published a guidance document dedicated to clinical evidence to be provided by medical device manufacturers when applying for marketing approval for the devices they are responsible for. In particular, the document describes in detail the regulatory requirements to be applied for each specific type of medical device. It is important to mention that the revised version of the said guidelines includes the sections dedicated to patient-matched, adaptable, and custom-made medical devices – due to the specific nature of such devices, the approach to be applied to clinical evidence for these products should be different as well. 

At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the way the relevant legislation should be interpreted, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with the applicable regulatory requirements.


Considerations for Custom-Made Medical Devices 

As it was mentioned before, the scope of the guidance covers, inter alia, the aspects related to custom-made medical devices – the ones that are for the sole use of a particular patient, or health professional (in the course of their practice), and are manufactured under particular design characteristics specified by a health professional in a written request to the manufacturer; while the design characteristics for custom-made medical devices must be intended to address the anatomical and/or physiological features, or the pathological condition, of the intended recipient. 

In such a case, it is presumed that there is no device already included in the Australian Register of Therapeutic Goods (ARTG), a country’s database for medical devices, which will meet in full the needs of a specific patient, hence, a new device is to be created to address them. As further explained by the HSA, custom-made devices are usually to be created when the characteristics required to meet the patient’s specific needs are falling outside the scope of the design envelope of a patient-matched medical device (as described in previous articles, a “design envelope” stands for a specification outlining the main characteristics of the device). To illustrate this, the authority describes a situation when due to the anatomical needs of a specific patient neither general nor existing patient-matches medical devices could be used since the said needs are beyond the boundaries of the respective design envelopes. 

From a regulatory perspective, custom-made medical devices are not subject to mandatory inclusion in the ARTG based on the respective exclusion. At the same time, as additionally emphasized by the authority, they should still comply with any Essential Principles which outline the key requirements in terms of safety and effectiveness for medical devices to be allowed for marketing and use in Australia. It is also stated that the manufacturers of such products are not exempted from complying with the clinical evaluation procedures set forth by the applicable legislation. 

The authority acknowledges that the clinical evidence for custom-made devices could be limited due to their unique nature. However, the manufacturer shall take into consideration the following factors: 

  • The reasons why a custom-made medical device was requested, include the determination by the requesting health professional that there is no kind of medical device available to address the condition of the intended recipient;
  • The design inputs and outputs; and
  • Pre-clinical and clinical data to support the claims on safety and clinical performance. Whilst the presence of any preclinical and clinical data should be considered before the issue of a custom-made device, this data will be of particular importance to maintaining in the post-market context. 

The authority additionally emphasizes the importance of ensuring that the potential users of such devices are provided with clear, understandable, and detailed enough instructions for use and other informational materials used to communicate safety- and use-related information and instructions to be followed; especially in case the custom-made device in question is based on a general (non-PMD) medical device, or such version of the product is available separately. 

To assist medical device manufacturers in applying the approach described hereinabove, the guidance also provides an example of the situation when the characteristics of a product requested by a health practitioner are falling outside the boundaries of the design envelope, and there are no devices with such characteristics placed on the market. Hence, in this situation, a unique device is needed to meet the patient’s needs. As explained by the TGA, the manufacturer of such a device would be obliged to keep records of the device specifications, clinical outcomes, and adverse events associated with the use of the device created. 


Additional Aspects 

Apart from describing the requirements for custom-made medical devices, the guidance also highlights certain important aspects to be considered concerning all non-serial devices, including patient-matched, adjustable, and custom-made ones. 

First of all, the authority mentions that the risks associated with such devices should be duly assessed, and the information about such risks should be communicated to potential users and healthcare professionals making decisions regarding the use of such devices. 

The authority further outlines the key consideration for the abovementioned device types, namely:

  • Clinical evaluation of patient-matched medical devices will center around the sufficiency of the clinical evidence to support safety and performance over the entire breadth of the design envelope. 
  • Similar to patient-matched medical devices, clinical evidence should support the safety and performance of adaptable medical devices and include an evaluation of point-of-care assembly or modifications.
  • Whilst custom-made devices are exempted from ARTG inclusion and therefore from pre-market submission of clinical evidence, they are still required to comply with the Essential Principles. 

In summary, the present TGA guidance describes in detail the regulatory requirements to be considered concerning clinical evidence for custom-made medical devices and outlines the key considerations associated thereto. The document also highlights the most important aspects related to all medical devices that are initially created or could be adapted to meet the needs of a specific patient. 


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