Technology changes have the potential to deliver significant advantages and opportunities to Australians. Ongoing advances are both disrupting and altering the health sector, where there is rapid change in the availability and type of medical devices intended to be customized for individuals. Sometimes, the treatment requirements of a specific patient cannot be met with commercially accessible mass-produced medical devices. In these cases, healthcare providers make, or provide specifications to a manufacturer to make, custom-made devices to meet the patients needs. 

However, medical devices are not without risk, and there is increasing attention globally of the patient safety issues that can arise with medical devices. Recent high-profile cases have brought into query  the effectiveness of the existing medical device regulatory frameworks; as a consequence, regulators around the world are increasing their scrutiny of the manufacture of medical devices.

There has recently been a survey of the medicines and medical device regulation, as well as a number of Senate inquiries on medical device regulation in recent years. In order to proceed to provide a high level of stringent oversight, the regulation of personalised medical devices is one such area that requires improved focus. 

Personalized medical device is a broad term used to describe all of the various types of medical devices that are intended to address the particular needs of an individual. As outlined above, these may be currently regulated as custom-made medical devices, medical devices assembled or adapted to suit an individual, and/or medical devices incorporating human-origin materials. 

This Regulatory Impact Statement is proposed to support  the decision on whether or not to introduce regulatory reforms for medical devices that are manufactured for specific patients (custom-made medical devices). These are devices that are captured in the current regulatory framework under:

• The custom-made medical device definition, and its corresponding exemption 
• Medical devices that are referred to in the definition of manufacturer under Section 41BG of the Therapeutic Goods Act 1989 (the Act) as devices already supplied but intended to be assembled or adapted to suit an individual; and
• Medical devices incorporating human-origin materials that are currently regulated as biologicals under the Act.

For personalized medical devices, third-party evaluation is not required. Manufacturers of personalized medical devices may instead make use of an exemption pathway, which largely only requires the manufacturer to:

• Advise the TGA that they are supplying particular kinds of personalized medical device; and
• Keep written records for each personalized device supplied and notify the TGA of any adverse events or recalls related to the custom-made medical device (retained for at least 5 years)

There are four significant differences in the way custom-made medical devices are regulated in comparison to other medical devices: 

• The conformity assessment procedure for custom-made medical devices, 
• Compliance with the essential principles, 
• Exemption from inclusion in the ARTG, and
• Record keeping and reporting.