Meeting 3D printing (additive manufacturing) rules for medical devices

3D printers

3D printers intended to manufacture medical devices are not independently regulated by us but are considered as part of the overall manufacturing process.  3D printers are considered manufacturing equipment and do not meet the definition of a medical device.

There are many 3D printing methods and processing steps that can be used to create medical devices. No specific brand of 3D printer is required for this purpose.

Overview of 3D printing

3D printing is a type of additive manufacturing. It enables the manufacture of complex 3D objects, shapes and textures. It uses raw materials such as polymers, resin, ceramics or metals in a layer-by-layer process. 3D printing is often used to produce personalised medical devices, for example:

• patient-matched models for pre-operative planning

• surgical guides 

• patient-matched permanent implants

The 3D printing workflow generally involves these main stages:

• Image acquisition or modelling 

• Generating an STL (stereolithography) file

• Slicing

• Printing

• Post-processing

Medical devices should be designed and manufactured to reduce risk. Manufacturers of 3D-printed medical devices must understand and describe material properties and processing requirements to minimise risks to users or patients.

Manufacturers must be able to show:

• how they mitigate any risks associated with the manufacture of a medical device; and
• that the medical device complies with all relevant Essential Principles.

Starting materials

Starting (raw) materials or components used in the manufacture of a medical device generally do not meet the definition of a medical device. Therefore, they do not need to be included in the Australia Register of Therapeutic Goods (ARTG) before they are supplied.

The exception is if a starting material meets our definition of a specified article. In this case, it is regulated as a medical device and must be included in the ARTG before it can be used in the manufacture of a medical device.

Examples of specified articles include: materials used in non-implantable dental appliances; materials used in externally applied orthopaedic devices.

Understanding specified articles and excluded products in personalised medical devices regulation

Starting materials may undergo significant physical or chemical changes during manufacture. Changes can affect the success of the printing process and the final device. Manufacturers should monitor the consistency and suitability of raw materials used.

Manufacturers must document manufacturing processes and material specifications as part of a quality management system.

When determining the suitability of a starting material, a manufacturer should consider:

• the material’s supplier, specification, and certificate of analysis
• the physical properties of the material (e.g. viscosity, melting temperature, purity)
• its biocompatibility with the human body
• the use of additives, crosslinkers, rheology modifiers or processing aids
• the degradability and leachables
• suitable post-printing processes.

Note. Biocompatibility is the ability of a material to perform safely within the human body without causing adverse reactions. One option for demonstrating it is using ISO 10993.

Cleaning the medical device

If your medical device is supplied non-sterile, it should be cleaned through a validated process before it is packaged for supply.

Cleaning can involve removing:

• physical,
• chemical, and
• microbial residue.

Sterilisation

If the device is intended to be sterilised, the manufacturer should include at least one validated cleaning procedure, and one validated sterilisation procedure in the Instructions for Use (IFU).

If your 3D-printed medical device is designed to be sterile, the sterilisation process must be validated.

Sterilisation standards can be found in:

• Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
  Lists sterilisation standards that can be used.

Note:

• 3D printing can result in air bubbles or pockets being present in the body of the device. As these air bubbles or pockets could be non-sterile, this poses a problem for sterilisation.
• Microbiological risks can arise if a sterile implantable device with air bubbles or pockets breaks or degrades.
• You will need to describe how you mitigated the risk of this outcome in your documentation.

3D biological printing or ‘bioprinting’ is an advanced form of 3D printing. It uses biological materials, including living cells, to create tissue-like structures. These cells can come from animals or humans, and can be primary cell lines or stem cells. The printed scaffold eventually degrades, leaving behind functional tissue in the desired shape and location.

Bioprinted implants are likely combination products and are generally regulated as a biological. Visit the combination biologicals webpage for more information.

US FDA - Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff