In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the market are safe, effective and of high quality. These principles, set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, are binding on all manufacturers wishing to market Medical Devices in the country.
To demonstrate compliance with the Essential Principles, manufacturers must gather scientific and clinical evidence closely related to the intended use of the device, clearly demonstrating compliance with safety and performance requirements.
The Essential Principles Checklist of August 22, 2024
An important update of the Essential Principles Checklist, a useful tool for identifying and documenting applicable safety and performance requirements, was published on August 22, 2024. The checklist helps to:
- identify relevant safety and performance requirements;
- document the reasons why any requirements might not be relevant;
- summarise the evidence supporting each safety and performance requirement.
Correct completion of the checklist facilitates the conformity assessment process and simplifies the preparation of the documentation required to obtain the certificate of conformity issued by the Therapeutic Goods Administration (TGA).
How to Use the Checklist
The checklist is to be used in various situations, such as:
- new conformity assessment applications for Medical Devices that have not yet been registered;
- substantial changes to devices already on the market that require reassessment;
- families or groups of devices: the checklist can be applied to a single device or a group of similar devices.
The correct completion of the checklist demonstrates how each Essential Principle has been addressed in the device development process. Manufacturers must retain it and provide it to the TGA when requested, e.g. in case of conformity assessment.
New Version of the Checklist
The checklist of the Essential Principles has been updated several times to improve its accessibility and usability. The latest version, published on August 22, 2024, introduced numerous improvements:
- removal of limitations that prevented the correct entry of data in the required fields;
- direct URL links to specific Essential Principles, to facilitate access to relevant information;
- introduction of a product section to indicate which device the checklist refers to, particularly useful for those who have to complete several models.
Conclusion
The Essential Principles checklist is an indispensable tool for medical device manufacturers, facilitating the demonstration of compliance with safety and performance requirements. Correct compilation and maintenance of the checklist enables manufacturers to ensure that their devices comply with current regulations and are ready to be placed on the market.
>>> Thema experts are at your disposal to help you reach the Australian medical device market in compliance with regulations.
