Understanding personalised medical devices rules (including 3D-printed devices)

Personalised medical devices are devices that are either designed and manufactured or modified, to suit an individual.

Other resources

The TGA understands that many manufacturers and suppliers of personalised medical devices are not familiar with the general principles and elements of medical device regulation. There are many resources available to assist you with understanding how medical devices are regulated in Australia including:

• Importing and supplying medical devices: information on how medical devices are regulated in Australia, including importing and supply rules for health professionals.
• Exempt medical devices: the regulatory obligations for exempt medical devices in Australia, including manufacturer responsibilities, safety, record keeping and compliance requirements.
• The Australian Regulatory Guidelines for Medical Devices: a range of information relevant to anyone who manufactures, imports, exports or otherwise supplies medical devices in Australia.
• The medical device inclusion process guidance: a step-by-step guide to applying to the TGA for regulatory approval of a medical device.
• SME Assist: a dedicated service that the TGA offers to help small-to-medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their legal obligations. The SME Assist website contains a range of resources to assist people who have not had dealings with the TGA before, including an overview of medical device regulation.
• The Medical Devices Information Unit (MDIU) are available to assist you with specific enquiries Monday to Friday, 8:30am – 5:00pm (AEST). You can contact the MDIU on 1800 141 144 or via devices@tga.gov.au.

The definition of a patient-matched medical device, as set out in the Regulations, is as follows:

patient-matched medical device means a medical device that:

1. is manufactured by the manufacturer, within a specified design envelope, to match:

   1. either or both of the anatomical and physiological features of a particular individual; or

   2. a pathological condition of a particular individual; and

2. is designed by the manufacturer (even if the design is developed in consultation with a health professional); and

3. is manufactured using production processes that are capable of being:

   1. either or both validated and verified; and

   2. reproduced.

Regulation of patient-matched medical devices 

The transition period for PMMDs will end on 1 July 2029. After this date all PMMDs (including notified PMMDs) must be included in the ARTG before they are imported into, supplied within, or exported from Australia (unless they are exempt, excluded or otherwise approved by us).

Exempt devices are exempt from inclusion in the ARTG, but they are not exempt from regulation. Manufacturers and sponsors of exempt medical devices still need to comply with TGA regulatory obligations for medical devices, including meeting the Essential Principles and advertising requirements.

GMDN terms for patient-matched medical devices

Patient-matched medical devices do not need special GMDN terms and may use the same GMDN terms used for devices that are not patient-matched. The manufacturer must choose the GMDN term that is most appropriate and best describes their device and how it is intended to be used, regardless of whether it is patient-matched or not.

Patient-matched medical devices can use GMDN terms that include ‘custom-made' in the title or description. GMDN terms are internationally agreed generic descriptors used to identify medical devices. The legal definitions for ‘custom-made' and ‘patient-matched' medical devices varies between jurisdictions. The descriptions used in GMDN terms use the phrase ‘custom-made” in line with the ordinary and natural meaning used in everyday language. Generally, you can use the term ‘custom-made' to indicate that a device is designed and manufactured to suit an individual.

For example, the most appropriate GMDN term for a patient-matched orthotic insole might be ‘GMDN 62870 - Orthotic insole, custom-made'. In this instance ‘custom-made' would simply mean a device personalised to meet an individual's specific requirements and the description could cover both patient-matched medical devices and custom-made medical devices.

If the manufacturer cannot find a suitable GMDN term to match the characteristics and intended purpose of their device, the manufacturer can contact the GMDN Agency and request assistance. In some cases, the GMDN Agency will need to create a new GMDN term.

Specified design envelope

The definition of a specified design envelope, as set out in the Regulations, is as follows:

specified design envelope means minimum and maximum dimensions, performance limits or other relevant factors that:

1. characterise a medical device for production purposes; and

may be based on a standard device template.

The specified design envelope is the limits of design that a manufacturer can be confident (with the support of objective evidence) will result in a medical device that is safe and fit for its intended purpose and will meet the intended recipient's requirements (i.e., design validation).

A design envelope may include several factors, such as:

• minimum and maximum dimensions
• performance limits
• allowable environmental limits for operation
• specifications for materials and their properties.

Factors that inform the specified design envelope could include:

• clinical research
• industry standards
• clinical practice guidelines
• specialist education or training
• on-the-job experience producing and using medical devices.

Example - Specified design envelope

Eleanor is a podiatrist who intends to produce patient-matched therapeutic insoles for her patients. As part of the technical documentation she is compiling through the conformity assessment process, Eleanor establishes and documents a specified design envelope for these devices.

Eleanor considers the following:

• the range of pathologies she knows she can treat using her patient-matched insoles, based on her training and professional experience and supported by knowledge held by her profession more broadly
• what design features she knows are suitable for use in treating each pathology (e.g., forefoot valgus wedge for treating plantar fasciitis)
• what materials she knows she can and cannot use for each kind of insole she produces
• the foot sizes she knows her equipment can and cannot accommodate.

While documenting this information, Eleanor notes that her specified design envelope is quite broad and consequently she is able to accommodate almost any patient who presents to her. This is because her devices and their use in clinical practice are very well-characterised within her industry. As a result, Eleanor is unlikely to ever need to produce a custom-made insole.

Eleanor concludes that her products are all patient-matched medical devices.

Production processes that can be validated and/or verified, and reproduced

Process validation, product verification and reproducibility are key concepts in medical device production.

Process validation refers to establishing, by objective evidence, that a process consistently produces a product meeting predetermined requirement. When used in the medical device context, process validation means a process has been subject to such scrutiny it can be virtually guaranteed to produce devices of a consistent quality. It is important to note that both automated and manual processes can be validated.

Validation is particularly important if the predetermined requirements of the product can only be assured by destructive testing. Factors such as production volume and number of manufacturing steps per unit may influence how process validation is undertaken. Manufacturers can, and should, seek out and select technology-specific guidance and applicable technical standards on applying process validation to their circumstances.

Verification refers to confirmation by objective examination of a product that the predetermined requirements of the product have been met. For example, measuring a device to ensure it has the required dimensions is an example of a verification procedure.

When process validation and product verification are applied, they result in production processes that will consistently produce devices that have similar characteristics, are of a similar quality and perform in a uniformly reliable manner. In other words, the outcome from the process is reproducible. This does not mean that any two devices produced are the same - only that the manufacture of all devices is underpinned by consistent factors that can be justified, ultimately ensuring that a medical device is safe and fit for its intended purpose and will perform as intended.

It is important to note that the manufacture of some medical devices, including those manufactured using additive or subtractive methods require humans to be involved in the production process - providing hand finishing and verification activities, for example. The involvement of a human factor in a manufacturing process does not mean that a manufacturing process cannot be validated and/or verified and reproduced.

More information

Other resources that may assist you to better understand these concepts, include:

• the Global Harmonisation Task Force (GHTF) document Quality Management Systems - Process Validation; and
• ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
• The International Medical Device Regulators Forum Personalized Medical Devices Working Group has produced three key documents that may assist you:
  • Definitions for Personalised Medical Devices
  • Personalised Medical Devices Regulatory Pathways
  • Personalised Medical Devices - Production Verification and Validation.

Example - Patient-matched medical device

Dean's company manufactures mass-produced orthopaedic implants but has also developed a capability to personalise certain devices in their catalogue where necessary. Dean is contacted by an orthopaedic surgeon who needs a personalised acetabular cage and cup manufactured for Dorcas, an 81-year-old female patient who needs to undergo a revision procedure complicated by complete loss of the anterior column and marked bone loss through the remaining acetabulum.

Dean reviews the information sent through by the surgeon including Dorcas' age, height, and weight, and determines that the design and production considerations for her device fall within the scope of what his company knows it can safely produce (i.e., their design envelope). The surgeon sends through CT imaging data to help inform the design of the device and consults with Dean's company on certain features such as how the device should attach to the bone. Dean employs the same production and verification methods to produce Dorcas' implant as he has for dozens of other personalised devices.

In this example, the device meets the definition of a patient-matched medical device because it:

• has been designed by the manufacturer within a specified design envelope to fit the particular anatomy and physiology of a particular individual; and
• has been produced using a process capable of being validated and/or verified and reproduced.

Counter example

Dean is contacted again by the orthopaedic surgeon, this time to manufacture an acetabular for Jake. Jake is a 43-year-old male patient who is 2.26 metres tall and weighs 160 kilos. Dean has never made an implant for someone so tall or heavy, and Dean determines that the dimensions and tolerances of the implant required for Jake fall well outside the design envelope that his company has validated. The surgeon has spoken to several producers and finds that Jake's requirements are not catered to by the design envelope of any patient-matched acetabular cage.

Dean uses the technical and design files to inform a modified device to meet Jake's requirements. He uses computer modelling to perform an engineering assessment to ensure the device he is producing will withstand the forces reasonably expected to be exerted during normal use but does not have the capacity to conduct a full clinical assessment or evaluation for what will be a one-off design. Dean communicates with Jake's surgeon, who uses his expertise and clinical judgement to inform the design of the device. Jake is made aware that his device is truly unique and informed about the risks associated with its use.

Dean employs the same production and verification methods to produce Jake's implant as he has dozens of other personalised devices.

The resultant device meets the definition of a custom-made medical device because the device:

• is intended for the sole use of the intended recipient (Jake)
• has been made at the request of a healthcare professional (the orthopaedic surgeon)
• who has determined that there are no alternative devices available on the ARTG to address the specific needs of this patient to an appropriate level
• does not meet the definition of a patient-matched or adaptable medical device.

In this case, while the manufacturing process can (and has) been validated, the device is being produced outside the design envelope. The resultant product therefore meets the definition of a custom-made device and will continue to be exempt from inclusion in the ARTG subject to the conditions outlined previously.

The definition of an adaptable medical device, as set out in the Regulations, is as follows:

adaptable medical device means a mass-produced medical device that is intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with the manufacturer's instructions, to:

1. address either or both of the anatomical and physiological features of a particular individual; or

2. address a pathological condition of a particular individual; or

3. otherwise perform as intended by the manufacturer.

The definition has been included in the Regulations for the sake of clarity but there is no change to the way devices that meet this definition are regulated. Adaptable medical devices continue to be regulated through inclusion in the ARTG under an appropriate classification.

Information to be supplied with an adaptable medical device

Essential Principle 13.4(3 - item 30) applies to adaptable medical devices and requires manufacturers of these devices to ensure that any adaptable medical device that they produce is supplied with instructions for assembling or adapting the device that, if followed by intended users, will ensure the device continues to comply with all relevant Essential Principles.

Example - Adaptable medical device

Tamara's company supplies a mass-produced polymer surgical implant for cranial reconstruction that is:

• supplied in a sterile state
• intended to be thermoformed during the cranial reconstruction procedure to suit the individual patient's anatomical features.

Tamara's implant meets the definition of an adaptable medical device because it is:

• mass-produced
• intended by the manufacturer to be assembled or adapted after it has been supplied to address an anatomical feature of the intended recipient.

4. Under the new personalised medical devices framework this product will continue to require an inclusion in the ARTG before it can be supplied. It will also need to be supplied with instructions for use that will allow the surgeon using it to safely heat and shape the polymer to suit the patient's anatomy, ensuring the device continues to be safe and fit for its intended purpose after it has been adapted.

Counter example - not a manufacturer

Brett is a rehabilitation engineer. During a consultation, a patient who wears an off-the-shelf ankle-foot orthosis (AFO) asks for Brett's help as she is finding the AFO painful to wear. Brett reviews the AFO, and determines some minor adjustments can be made, such as the addition of some padding, to address this issue for the patient.

Brett wants to understand if he will become the manufacturer of an AFO if he makes these adjustments.

Brett reviews the information available on the TGA website and notes that under section 41BG(3) of the Act, a person does not meet the definition of a manufacturer if:

1. the person assembles or adapts the device for an individual patient

2. the device has already been supplied by another person

3. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

   1. the labelling on the device

   2. the instructions for using the device

   3. any advertising material relating to the device

   4. technical documentation describing the mechanism of action of the device.

Brett determines that the modifications he has made, while not necessarily intended by the manufacturer of the AFO, do not make him the manufacturer because the modifications do not change any of the features listed under (c) above.

The below is a summary only.

Detailed information about the regulatory requirements that specifically apply to custom-made medical devices is available on the TGA website: Custom-made medical devices: Information for sponsors, health professionals & manufacturers.

The definition of a custom-made medical device, as set out in the Regulations, is as follows:

custom made medical device means a medical device that:

1. is intended by the manufacturer to be for:

   1. the sole use of a particular patient (the intended recipient); or

   2. the sole use of a particular health professional (the intended recipient) in the course of the health professional's practice; and

2. is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:

   1. either or both of the anatomical and physiological features of the intended recipient; or

   2. a pathological condition of the intended recipient; and

3. the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.

However, a custom-made medical device does not include a patient matched medical device, an adaptable medical device or other mass-produced medical device.

Custom-made or patient-matched

Both custom-made and patient-matched devices are designed and produced for a particular individual. In addition, both custom-made and patient-matched medical devices can be manufactured in accordance with a written request from a health professional. The key difference between these definitions is that a custom-made device is so rare and unique that there is no way that the manufacturer can adequately validate the design of the device, or adequately validate and/or verify the production process, at the time it is requested.

Custom-made medical devices can only be produced and supplied where a patient's particular circumstances mean that there is no other suitable device available in the ARTG for use in their treatment.

If you manufacture a medical device in accordance with the written request of a health professional to suit an intended recipient, it does NOT mean that your device is custom-made.

Both custom-made and patient-matched medical devices can be manufactured in accordance with the written request of a health professional. This is not a distinguishing feature for custom-made medical devices.

Wherever possible, patients and health professionals should access medical devices that are ARTG-included and supported by appropriate evidence of their quality, safety and performance. The custom-made medical devices exemption addresses the rare circumstances where the rarity of the clinical presentation and needs of the end-user limit the availability of evidence.

When a device is exempt from inclusion in the ARTG, it does not mean the device is exempt from TGA regulation entirely. Manufacturers and sponsors of custom-made medical devices still have regulatory obligations that they must meet under TGA legislation.

Example - Custom-made medical device for a patient

Samara is an orthopaedic surgeon. Samara is asked to review a patient who presented to the emergency department with loss of elbow function and severe pain following a traumatic fall. CT imaging demonstrates significant injury to the radial head, with loss of viable bone throughout the proximal portion of the radius. Samara determines the radial head will need to be replaced to restore functionality to the elbow; however, the loss of bone in the proximal portion of the radius is significant.

Samara determines there is no device included in the ARTG that could be used to reconstruct the radial bone. She approaches a manufacturer of orthopaedic devices to request they produce a proximal replacement radius for the patient, making use of the patient's own bone to form part of both the matrix and reinforcement component of the replacement implant. Samara uses her knowledge and experience as an orthopaedic surgeon to determine key design characteristics (including the angle of the radial head to the stem and the composition of materials) that should provide the best outcome for the patient.

Samara provides these characteristics and the patient's CT scanning data to the manufacturer to help inform part of the design. The manufacturer designs and produces a proximal radial implant for the patient based on the information supplied by Samara.

In this example, the proximal radial implant is a custom-made medical device because the device:

• is intended for the sole use of the intended recipient
• is designed with particular design characteristics (e.g., the angle of the radial head to the stem) specified by a health professional (Samara) to address the anatomical features of the intended recipient
• was manufactured because there were no alternative devices available on the ARTG to address the intended recipient's needs to an appropriate level, owing to the degree of injury and its rarity
• does not meet the definition of a patient-matched medical device because although the manufacturer has experience with these types of device, the degree of bone loss means they have had to design this device well outside the parameters of their specified design envelope
• does not meet the definition of an adaptable medical device because the device is not mass produced, and is not intended to be adapted after supply.

Example - custom-made medical device for a health professional

Tony is a gastroenterologist who has lost some dexterity because of nerve damage sustained during an accident. He employs a biomedical engineer to design and manufacture a modified steering mechanism for an endoscope to help him manage the loss of dexterity, thereby allowing him to continue operating the endoscope safely. Tony dictates the design characteristics that he will need for the steering mechanism including the level of responsiveness needed.

The engineer devises a solution to fit. In this example, the steering mechanism will meet the definition of a custom-made medical device because the device:

• is intended for the sole use of the intended recipient (the gastroenterologist);
• is designed by a health professional (Tony) to address the physiological features of the intended recipient;
• was manufactured because there were no alternative devices available in the ARTG to address the intended recipient's needs;
• does not meet the definition of a patient-matched medical device because it has been produced outside of the manufacturer's specified design envelope as a one-off for Tony; and
• does not meet the definition of an adaptable medical device because it is not being mass-produced, and it is not intended to be adapted after supply.

Counter example - not a custom-made medical device

Sharni's company produces personalised maxillofacial plates that can be manufactured to suit a patient's unique anatomy. DICOM files are sent to Sharni by each referring surgeon. Sharni imports the DICOM file data to her computer-aided design and manufacture (CAD/CAM) program and designs a plate to fit the patient's specific defect.

Sharni confirms the design with each requesting surgeon before commencing production of the final device.

Sharni's maxillofacial plates will not meet the definition of a custom-made medical device because they are manufactured:

• within a specified design envelope; and
• using production processes that can be validated and/or verified, and reproduced.

Sharni's plates meet the definition of a patient-matched medical device. 

Medical Device Production Systems (MDPS) are a new regulatory concept, designed to provide options to healthcare facilities wanting to produce patient-matched device in-house for treating their patients.

In the future, manufacturers and/or sponsors may be able to include an MDPS in the ARTG. For this to happen, a legislative instrument will need to be established.

If you would like more information about MDPS please see:

• Medical Device Production Systems
• Medical devices reforms: personalised medical devices