The Therapeutic Goods Administration (TGA), an Australian regulating authority responsible for medical devices, has issued a guidance document dedicated to the use of three dimensional (3-D) printing (an additive manufacturing process).
Technology Overview and Regulatory Background
According to the TGA guidance, 3-D printing technology includes two key processes:
- developing the object using computer-aided-design (CAD) software or a 3-D scanner, and
- manufacturing the object by depositing the material in layers.
The authority acknowledges that the aforementioned technology is being actively used nowadays to manufacture medical devices due to the significant advantages and new opportunities it creates. The manufacturers that use 3-D printing technology should also consider certain risks associated thereto, and to take all measures reasonably necessary to mitigate such risks to the lowest extent possible, in order to ensure the safety and effectiveness of all medical devices placed on the Australian market.
The TGA guidance on 3-D printing of medical devices is intended to provide medical device manufacturers with important information and recommendations and to assist them in achieving and sustaining compliance with the applicable requirements.
Risk Management Requirements for 3-D Printed Medical Devices
The TGA outlines the most important requirements related to risk management. In particular, the authority emphasizes on specific risks arising from the technology itself and its features, even if the medical devices with the same design (but manufactured in a traditional way) are already marketed in Australia.
When applying for medical device marketing approval in Australia, the manufacturers shall demonstrate:
- the approaches used to reduce and mitigate identified risks associated with the specific features of the 3-D printing technology itself, and
- compliance with the applicable essential principles.
3-D printed medical devices should also be subject to conformity assessment in accordance with the procedure set forth by the Therapeutic Goods (Medical Devices) Regulations 2002.
Materials to be Used in Additive Manufacturing of Medical Devices
Another important aspect to be considered by the manufacturer relates to the materials used for the device. In particular, such materials should be suitable for both the manufacturing process and the intended purpose of the device.
In particular, the approach to the materials used should be based on the following:
- Biocompatibility issues are especially important for the devices intended to be used inside the human body or a body orifice. This requirement also covers the issues related to substances leaching from the device. The authority states that the manufacturer shall evaluate any and materials used and to provide information about their characteristics and features. It is also recommended to make references to the international standard ISO 10993 with regard to the biocompatibility requirements.
- The stability of the materials is of the essence for those 3-D printed medical devices intended to be used for a relatively long period of time. In particular, the manufacturer shall ensure the materials used to manufacture the device remain unchanged and compliant with the applicable safety requirements within the whole expected life of the device.
- The materials used for sterile medical devices should be compatible with the sterilization method used by the manufacturer.
Sterilization and Cleaning the 3-D Printed Medical Device
If the particular device is not sterile, the manufacturer shall take necessary steps to clean the device before packaging it in order to remove physical or chemical residues. Sometimes such devices could be intended to be cleaned or sterilized by the end-user himself. In such a case, the manufacturer of the device should provide a detailed description of the applicable cleaning and sterilization procedures. The descriptions of validated procedures should be included in the Instructions for Use.
In the case of sterile 3-D printed medical devices, the appropriate sterilization method should be applied. In accordance with the applicable regulations, such a sterilization process should be duly validated. With regard to the requirements on sterile medical devices, the TGA refers to the following regulations:
- The Therapeutic Goods (Manufacturing Principles) Determination 2020, providing that any and all medical devices bearing the label «Sterile» should be manufactured in compliance with EN556 to a Sterility Assurance Level (SAL) of 10-6,
- The Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, which indicates the sterilization standards the manufacturer shall use.
The FDA also recommends that manufacturers pay special attention to the air bubbles or pockets that could appear due to the specific features of the manufacturing process since such defects could impact the sterility of the device.
According to the guidance, the manufacturer of 3-D printed medical devices should duly document all potential risks associated with the sterility of the device and describe the measures taken to mitigate such risks.
Regulation of 3-D Printed Medical Devices in Other Countries
When describing the regulatory approach to 3-D printed medical devices adopted by the Australian regulating authority, it is important to mention that similar guidance documents have been already issued by some of the national regulating authorities. In particular, similar guidance documents have been already issued by the Canadian authority Health Canada and the UK`s MHRA. At the same time, the scope of these documents differs substantially:
- Health Canada’s guidance on 3-D printed devices is mostly dedicated to the implantable ones. The document describes the requirements applicable for the 3-D printed implantable medical devices in Canada, special tests, and examinations such devices should be subject to. According to the document, the premarket review process for the aforementioned devices should cover such aspects as physical testing, mechanical testing, biocompatibility testing, software validation, and clinical effectiveness evidence. The document also provides a brief overview of the Canadian domestic market of 3-D printed medical devices in general.
- The MHRA`s guidance on 3-D printed medical devices describes the way such devices should be treated in the context of the COVID-19 outbreak. The British authority states that 3-D printing technology could be used to expand and ensure the availability of vitally important medical devices during the pandemic. In particular, the guidance covers the cases of using the additive manufacturing technology to create personal protective equipment and medical devices used by healthcare institutions when addressing the disease. The MHRA guidance also describes the regulatory approach introduced by the authority to simplify marketing such devices in order to avoid potential shortages.
Irrespective of the particular regulatory measures, all aforementioned regulating authorities acknowledged the importance of the 3-D printing (additive manufacturing) technology in manufacturing medical devices of various types.
Summarizing the information provided hereinabove, the TGA guidance on 3-D printing of medical devices describes the regulatory framework existing nowadays and provides the manufacturers with recommendations to be considered when applying for marketing approval. In particular, the authority describes in detail the requirements related to the materials used in the manufacturing process.
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