The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to personalized medical devices. The document provides additional clarifications and recommendations regarding the medical devices issued in accordance with the request issued by the healthcare professional and intended to match the needs of the particular patient.
Obligations of the Medical Device Manufacturer
The applicable legislation prescribes the scope of information to be provided by the medical device manufacturer in order to ensure that all the parties involved in operations with medical devices, including healthcare professionals and patients, are duly informed about all important aspects associated with the use of such devices, especially in terms of risks and safety measures. The information to be provided, and the way the information should be provided depends on the following:
- Whether the patient would consult with healthcare professionals other than the one that requested the medical device?
- Which information is necessary to ensure the operations of a medical device in a safe and efficient manner?
- Which information should be provided with regard to the potential modifications to a medical device?
- In which way the medical device should be used?
According to the document, the medical device manufacturer is obliged to keep the records with regard to compliance of a medical device with the Essential Principles. In particular, starting from February 25, 2021, the medical device manufacturers have to keep a copy of the statement supplied with the product, as well as any additional documentation associated thereto not less than:
- 5 years in the case of non-implantable medical devices, and
- 15 years in the case of implantable medical devices.
Moreover, in accordance with the applicable regulations, the medical device manufacturers are obliged to submit annual reports containing the information about any and all custom-made medical devices they have manufactured and supplied within the previous financial year. Such a report should be based on the appropriate template developed by the TGA. As it is stated in the guidance, an annual report shall contain:
- The date when the medical device manufacturer has notified the regulating authority about manufacturing and/or supplying medical devices;
- The overall number of medical devices supplied in the reporting year;
- A statement confirming compliance with the reporting requirements;
- The appropriate Device Incident Report (DIR) numbers for all adverse reports submitted to the regulating authority;
- The information about the corrective actions taken or notifications made by the medical device manufacturer.
The TGA additionally emphasizes that in case of failure to comply with the aforementioned requirements, the medical device manufacturer could be subject to fines and penalties. Later the reporting procedures related to the custom-made medical devices would be merged with the general reporting requirements for medical devices.
Inspections and Reviews
The present document also describes in detail the inspections and reviews to take place in the context of custom-made medical devices. According to the document, the manufacturer or the sponsor of a personalized medical device shall be able to provide upon request:
- Sufficient information to substantiate the conformity assessment procedures prescribed under Part 7.2 of Schedule 3 of the Regulations have been applied to the device; and
- Information relating to the design and manufacture of the device and any changes made to the device.
Moreover, the medical device manufacturers supplying personalized medical devices could be subject to the inspections to be conducted by the representatives of the regulating authority. In this regard, the following obligations are arising:
- To provide access to the premises (manufacturing facilities). According to the TGA guidance, an authorized person is entitled to attend manufacturing facilities located both in Australia or in other countries in order to inspect the premises themselves or the medical devices being manufactured therein, and also to capture images or recordings.
- To provide documentation. The TGA may also request the medical device manufacturer to provide the appropriate documentation related to a medical device, including, inter alia, a copy of the initial request for a personalized medical device submitted by the healthcare professional, any information supplied with the product, and also the sufficient evidence of conformity assessment documentation.
The TGA guidance also outlines the notification timelines to be applied in case of the aforementioned inspections. According to the document, the regulating authority will duly notify the medical device manufacturer about the upcoming planned inspection in 2 weeks in advance in case of domestic inspection, and in 4 weeks in case of a foreign one. However, in case if an inspection has been initiated in the context of a serious compliance investigation, the notification timelines may be different.
Guide for Manufacturers of Personalised Medical Devices
The present TGA guidance provides step-by-step recommendations to be followed by the medical device manufacturers intended to produce and supply personalized (custom-made) medical devices. According to the guidelines issued by the regulating authority, a medical device manufacturer shall:
- Duly submit the appropriate notification to the regulating authority via the online reporting form. Such a notification should be submitted 2 months prior to the actual manufacturing or supply of the medical device.
- Create a statement to be supplied together with the product.
- Fulfill the obligations on the record-keeping outlined hereinabove.
- Ensure the access of the representative of the regulating authority to the manufacturing facilities.
- At the end of the financial year – submit the appropriate annual report.
Patient-Matched Medical Device
The TGA guidance also provides additional clarifications and recommendations related to the patient-matched medical devices. In accordance with the definition provided by the TGA, a patient-matched medical device is the one manufactured to match either or both of the anatomical and physiological features of a particular individual; or a pathological condition of a particular individual. It is also closely related to the concept of a specified design envelope, which stands for the minimum and maximum dimensions, performance limits, or other relevant factors that (a) characterize a medical device for production purposes; and (b) may be based on a standard device template. In other words, a specified design envelope outlines the particular limits within which production and operation of a medical device have been validated, including its dimensions, performance, and environmental limits, and also specifications for materials and their properties.
Other important concepts associated with the patient-matched medical devices include process validation, product verification, and reproducibility.
Process validation prescribes that the medical device manufacturer shall develop and implement the process ensuring the consistency in quality of medical devices and their compliance with the predetermined requirements.
Verification should take place in order to ensure the particular patient-matched medical device meets the predetermined requirements.
The whole manufacturing process should be reproducible, providing that any and all medical devices are compliant with the appropriate requirements.
Summarizing the information provided here above, the present TGA guidance highlights the most important aspects associated with the personalized (custom-made) and patient-matched medical devices. In particular, the document describes the information to be provided by the medical device manufacturer, the obligations and responsibilities of the latter, and also outlines the key points related to the patient-matched medical devices and the main concepts associated thereto.
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