The Therapeutic Goods Administration (TGA), under the Australian Department of Health and Aged Care, is responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods. They regulate medicines, medical devices, and biologicals to help Australians stay healthy and safe.

Manufacturers are responsible for generating, collating, assessing, and maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles. The evidence must be relevant to the device's intended purpose and must be objective, sufficient, and robust. Manufacturers manage this by having a solid, quality management system (QMS).

An ‘Essential Principle’ is fulfilled during the design and manufacturing of medical devices and IVD medical devices, to ensure that they are safe and perform as intended. A global adoption of a common set of fundamental ‘essential’ design and manufacturing requirements for medical devices provides significant benefits to, among others, manufacturers, users, patients/consumers, and to regulatory authorities. From a high-level perspective, three basic points make up ‘Essential Principles’:

• A device must be designed to be safe and perform effectively throughout its lifecycle.

• Device manufacturers must maintain all design characteristics.
• A device must be used in a way that is consistent with how it was designed.

Many countries use the term ‘Essential Principles’ (EP's) in regulations and guidance documents. ‘Essential Requirements’ is the terminology used in the EU MDD 93/42/EEC and AIMD 90/385/EEC. With the release of the MDR/IVDR, they are now referred to as GSPR's (general safety and performance requirements). Regardless of the terms used, Essential Principles are of similar nature and overlap many of the Essential Requirements in the new GSPRs.

Demonstrating Compliance

It is the manufacturer’s responsibility to demonstrate that their medical device is compliant. The TGA’s regulatory process does not necessarily dictate “how” a manufacturer must demonstrate compliance with the Essential Principles. However, there is a range of data points that are suggested to be used as objective evidence to show that your device complies with the Essential Principles. Listed below are some examples of the data you would want to track and list in your Essential Principles documentation, commonly referred to as The Essential Principles Checklist or GSPR’s.

Details of design and construction:

• a general description of the medical device and its intended purpose
• specifications, protocols, procedures, and details of design and development methods, and technologies used for manufacturing, packaging, storage, handling and distribution
• procedures for measuring and monitoring the safety, performance, and quality of your device
• procedures for servicing (if appropriate)
• procedures for assuring your medical device is sterile (if appropriate)

Risk management reports:

• risk analysis
• risk evaluation
• identification of residual risks
• controls of known and foreseeable risks

Demonstrate compliance with relevant, generally acknowledged state-of-the-art and best-practices:

• technical standards, guidelines, or other validated methods
• codes of practice
• monographs

Characterization studies:

• Verification and validation activities, including protocols, testing and analysis.
• Records of qualitative or quantitative information obtained through observations, measurements, and tests.

Clinical evidence:

• literature reviews that include information about the hazards and associated risks from the use and potential misuse of the device.
• information about the performance of the devices you are manufacturing, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose or not.
• Collation and analysis of post-market data including complaints, adverse-event reports, vigilance reports, registry data and recalls/field corrections/advisory notices.

Additional information:

• Copies of labels, packaging, patient information, and instructions for use.
• Critical evaluation written report, by an expert in the relevant field, of data (including outcomes from literature reviews) about your device.

Essential Principles checklist

The checklist is a form template that the TGA created for medical device manufacturers. It lists all the necessary requirements that must be met, as part of the technical file, to demonstrate regulatory compliance. It’s structured in a table format with each general principle clearly stated with instructions on how to complete the form (Fig 1).  

The TGA follows the guidelines of the International Medical Device Regulators Forum (IMDRF). They were one of the founding members to take part in the IMDRF that was established in 2011, building off the groundwork of the Global Harmonization Task Force (GHTF). Today there are 11 countries that participate in accelerating international medical device regulatory harmonization. This group of regulators provide input to policies, offer guidance on strategies, create clear directions - all in an effort to help build a strong foundation for the safety of the medical device industry.  

For additional information on Australian medical device regulations and links to resources, see our Australia Regulatory Market Profile. For information on the use of essential principles in the EU, see The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR).

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