The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to proposed changes to the regulatory requirements for personalized medical devices. Apart from the general approach, the guidance also describes in detail some specific aspects to be considered by the medical device manufacturers and other parties involved.
Exemptions for Patient-Matched Medical Devices
As mentioned, the suggested framework provides certain exemptions for low-risk patient-matched medical devices. According to the consolation paper published by the TGA, Class I patient-matched medical devices could be exempted from mandatory inclusion in the Australian Register of Therapeutic Goods (ARTG), provided the appropriate preconditions are met.
In particular, in order to be eligible for such an exemption, the devices should be manufactured:
- By a healthcare institution which has been duly accredited by a body recognized by the Australian Commission on Safety and Quality in Health Care (ASCQHC), provided the scope of such accreditation covers the National Safety and Quality Health Service (NSQHS) Standards;
- By an entity which has been duly registered with the National Disability Insurance Scheme Quality and Safeguards Commission (NDISQSC), provided that such a registration covers the products in question;
- By a healthcare professional who is duly registered with the Australian Health Practitioner Regulation Agency (AHPRA) in accordance with the applicable legislation, namely, the Health Practitioner Regulation National Law Act 2009, provided the registration covers the appropriate type of medical devices.
The points above apply if the patient-matched medical device in question is produced solely to be used within the appropriate healthcare institution or by the same healthcare professional, a recognized dental technician, dental laboratory, orthodontist, or prosthetist.
The TGA further provides some examples of patient-matched medical devices falling within the scope of the aforementioned exemption. Such devices include occlusal points, aligners, non-invasive orthoses and prostheses, plagiocephaly helmets.
Should the recommendation to apply an exemption for Class I low-risk patient-matched medical devices be adopted and implemented, the responsible entities would no longer need to apply for inclusion of such devices in the national register. However, all other regulatory requirements for medical devices would remain applicable. For instance, such devices should still comply with the applicable Essential Principles, especially the ones related to labeling and instructions for use to be provided with the device; as well as the regulatory requirements related to a declaration of conformity and incident reporting (the medical device manufacturers and other parties responsible for medical devices placed on the market would still have to report to the regulating authority the adverse events occurring during the use of their devices in accordance with the intended purpose). The TGA also mentions that since the devices would not be included in the ARTG, it would not be allowed to offer them to the general public. Moreover, the suggested approach should not be applied in the case of higher-risk patient-matched medical devices (Classes IIa, IIb, or III).
Inclusion in the ARTG Under Alternative Procedure
The document also describes how patient-matched medical devices could be included in the ARTG under the alternative conformity assessment procedure. The suggested approach applies to Class IIa patient-matched medical devices that are low-medium risk products. According to the current regulatory requirements, the medical device manufacturer producing such devices should have a quality management system (QMS) certified by the regulating authority or a third-party conformity assessment body. Additionally, medical device manufacturers shall duly have in place the evidence sufficient to demonstrate that their products comply with the applicable Essential Principles.
According to the consultation paper, the patient-matched medical devices falling within the scope of this rule include the following:
- Dental devices that are intended to remain in the oral cavity for more than 30 days continuously; and
- Orthoses that are intended to penetrate the skin and be anchored within the body.
The authority states that in certain cases, such devices could cause significant harm, including both biological and technical complications. Thus, it becomes vitally important to ensure the stability of the device structure. Due to the fact that operations with such devices require input from healthcare professionals, and also due to the significant risks associated with such devices, the TGA does not find it suitable to exclude or exempt them from mandatory inclusion in the national register. However, an alternative conformity assessment procedure could be applied in order to reduce the regulatory burden for medical device manufacturers, provided that the risks associated with both manufacturing and use of the product could be managed in an efficient way.
For this purpose, the following conditions should be met:
- The device is manufactured by a trained, accredited professional; or
- Other third-party mechanisms of oversight are in place that are suitable to manage the low risk that the device may pose.
Under the alternative conformity assessment procedure, medical device manufacturers will have to carry out a self-assessment and provide a declaration confirming its compliance with the applicable regulatory requirements. In particular, it will be necessary to demonstrate that the medical device in question complies with the applicable Essential Principles. A special self-assessment template is to be developed by the regulating authority for this purpose. According to the new approach suggested, when applying for inclusion of their product in the ARTG, medical device manufacturers will have to submit the filled template and the appropriate declaration. As mentioned, inclusion in the national register will still be required before the product will be allowed for marketing and use in Australia.
According to this approach, medical device manufacturers will have to:
- Prepare and hold technical documentation in relation to the kind of device to enable assessment of the device; and
- Hold evidence that the device meets the Essential Principles; and
- Establish and keep up-to-date a post-market monitoring, reporting and corrective action system.
Once the approach described above is implemented, medical device manufacturers will no longer need to obtain QMS certification. This will reduce the regulatory burden medical device manufacturers are facing while ensuring a sufficient level of regulatory oversight. The scope of application of an alternative conformity assessment procedure is also limited. According to the TGA consultation paper, it could be applied in the case of personalized medical devices manufactured by healthcare institutions or healthcare professionals for their own use. The authority additionally emphasizes that the suggested approach should not be applied to Class IIb and Class III medical devices as they are associated with higher risks.
In summary, the TGA consultation paper describes the new approach suggested by the Australian regulating authority with regard to patient-matched medical devices. The document describes the alternative solutions that are expected to reduce the regulatory burden and facilitate placing new devices on the market while ensuring they still meet any and all applicable regulatory requirements.
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