Australia’s Therapeutic Goods Administration (TGA) has published updated guidance dedicated to personalized medical devices. Apart from other aspects, the document addresses the regulatory matters related to the medical device production systems (MDPS).

Regulatory Background 

According to the Medical Devices Regulations, a medical device production system is a system that consists of raw materials and main production equipment (whether or not the system also consists of software), where the system is intended by the manufacturer to be used (whether or not with ancillary inputs or equipment) by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for use in relation to a patient of the health professional or healthcare facility. This concept was introduced in order to provide healthcare institutions with additional flexibility. The appropriate regulatory framework is still under development and is not fully operational. The authority emphasizes that as of today, this facility is not currently available and an MDPS cannot be approved by the TGA or included in the ARTG at this time. Hence, healthcare facilities that will later benefit from the implementation of a new framework now meet the definition of a medical device manufacturer and thus should comply with any and all applicable regulatory requirements. 

According to the chart provided in the present guidance, a medical device production system includes such components as:

  • Raw materials;
  • Manufacturing equipment;
  • Design. 

As a result, patient-matched medical devices should be produced. 

It is further stated that the conformity assessment to be performed in the context of inclusion of an MDPS in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of healthcare products, should also include the assessment of a medical device to be produced. Later, when the system is used, there will be no need to conduct conformity assessment for medical devices manufactured or include it in the ARTG. 

Use of MDPS

The TGA document further highlights the most important aspects related to the use of medical device production systems. In particular, once the new framework will become effective, healthcare professionals will be allowed to use medical device production systems under the following conditions:

  • The system used has been duly included in the national register of therapeutic goods; and
  • The system will be used strictly as prescribed by its manufacturer.

Should the abovementioned points not be met, an entity manufacturing medical devices should comply with any and all applicable regulatory requirements related to medical devices. 

The new approach reduces the regulatory burden the entities involved are subject to as the points below would be no longer applicable:

  • Mandatory conformity assessment procedures for a medical device,
  • Inclusion to the national register of therapeutic goods.

Suitably Qualified Person 

One of the most important concepts used in the context of personalized medical devices is a “suitably qualified person.” This category covers healthcare professionals working in healthcare facilities. The definition of a healthcare professional is provided in the current regulation. According to the aforementioned definition, a health professional is defined as a person who is:

  1. A medical practitioner, a dentist or any other kind of health care worker registered under a law of a State or Territory; or
  2. A biomedical engineer, chiropractor, optometrist, orthodontist, osteopath, pharmacist, physiotherapist, podiatrist, prosthetist or rehabilitation engineer. 

In general, the concept of healthcare professionals covers all the specialists that are working in healthcare institutions and provide healthcare services themselves or support healthcare professionals. 

The concept of a “suitably qualified person” is a bit more complicated. According to the guidance, the level of qualification needed to be allowed to use the medical device production system should be determined on a case-by-case basis depending on the medical device in question, as well as the MDPS used. The authority additionally emphasizes that the manufacturer of an MDPS will be required to state in the instructions for use the requirements they have of a “suitably qualified” user. Such an indication covers minimum requirements with regard to qualifications and experience, as well as any applicable accreditation, or sometimes participation in the courses organized by the medical device manufacturer or a third party. 

It is important to mention that if the entity using the medical device production system fails to comply with the requirements set forth by the manufacturer with regard to qualified persons, such use will be deemed beyond the scope of the general concept. Hence, such an entity will be considered a medical device manufacturer. Consequently, any and all requirements medical device manufacturers are subject to would be applied. In this regard, the authority reminds that making medical devices available for healthcare professionals and users without the inclusion of such devices to the appropriate national register of therapeutic products constitutes a violation of the applicable legislation. 

MDPS: Manufacturers and Sponsors 

The document also outlines the sphere of responsibility of the MDPS manufacturers and suppliers. According to the guidance, they shall ensure that:

  • The appropriate conformity assessment procedures have been applied to the MDPS relevant to its classification, demonstrating it, and all devices it produces, meet all relevant Essential Principles; and
  • The MDPS is included in the ARTG with the same classification as the highest class of the device it is intended to produce. 

The TGA additionally mentions that the parties involved in manufacturing and supplying medical device production systems are allowed to contact the TGA in order to get additional clarifications regarding the way the regulatory requirements should be applied in order to achieve and sustain compliance thereto. 

In order to assist the MDPS manufacturers in applying the new regulatory framework, the TGA also provides several examples describing the particular way compliance with the new requirements should be achieved. One of the examples describes a situation when the manufacturer provides a 3D printing system intended to be used to manufacture certain medical devices. In this regard, the authority emphasizes the following:

  • The entity which combines all system elements together and indicates the intended use in documentation accompanying the system will be considered as medical device production system’s manufacturer, even if some of the components of the system are actually manufactured by third parties. Hence, such an entity will have to ensure compliance with the applicable requirements for medical device manufacturers. 
  • The scope of MDPS components supplied should be determined on a case-by-case basis depending on the specifics of the system. For instance, in this particular example, raw materials should be supplied by the MDPS manufacturer as well due to the fact that the quality of medical devices manufactured by virtue of 3D printing significantly depends on the quality of the raw materials used. At the same time, if some elements or components are not critical in terms of the safety and performance of final devices, it could be sufficient to indicate the requirements such components should meet. 
  • The MDPS should also indicate the skills and qualifications necessary to operate the medical device production system. 
  • In order to ensure consistency in the quality of medical devices manufactured when using the MDPS, the manufacturer should provide detailed instructions on the Quality Assurance. Moreover, in certain cases, it could be reasonable to provide calibration services. 

In summary, the present TGA guidance describes the basics of a new regulatory framework for medical device production systems. The document describes the applicable regulatory requirements and highlights the most important aspects to be considered. 

Sources:

https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices 

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