TGA continuously adopts several relevant approaches applied by consensus groups, such as the IMDRF or local authorities, and subsequently incorporates them with modifications - as needed for the Australian condition - into its guidelines.
Respectively, the newly released version 3.1. of the clinical evidence guideline provides information on the following aspects:
- - Legislative framework
- - The Essential Principles
- - Clinical evidence requirements
- - Sources of clinical data
- - Clinical evaluation and the Clinical Evaluation Report (CER)
- - Comparable devices including substantially equivalent devices
- - Requirements for specific device types
In Australia, Medical devices are regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. Throughout the lifecycle of all Medical Devices (MD), it is required to have ongoing compliance with the Essential Principles (EPs)
The manufacturer must ensure that the clinical evaluation procedures described in Part 8 of Schedule 3 of the MD Regulations, the clinical data, such as investigation data or literature reviews, must be evaluated by competent clinical experts. Furthermore, clinical evidence must demonstrate compliance with the applicable EPs with corresponding documentation.
Competent requirements related to safety and performance characteristics are set in 6 general principles and 10 specific principles. The sponsor and manufacturer are both responsible to provide genuine and complete evidence from the basis of available scientific knowledge.
A summary of the Essential Principles:
• Principle 1: Use not to compromise health and safety
• Principle 2: Design and construction to conform with safety principles
• Principle 3: Must perform the way the manufacturer intended
• Principle 4: Must be designed and manufactured for long-term safety
• Principle 5: Must not be adversely affected by transport or storage
• Principle 6: Benefits must outweigh any undesirable effects
• Principle 7: Chemical, physical, and biological properties
• Principle 8: Infection and microbial contamination
• Principle 9: Construction and environmental properties
• Principle 10: Principles for medical devices with a measuring function
• Principle 11: Protection against radiation
• Principle 12: Medical devices connected to or equipped with an energy source
• Principle 13: Information to be provided with a medical device
• Principle 13A: Patient implant cards and patient information leaflets
• Principle 14: Clinical evidence
• Principle 15: Principles applying to IVDs only
The type of evidence required to demonstrate compliance with the EPs will depend on the intended purpose, risk profile, classification, and other specific functions of a device.
In Australia, a substantially equivalent device does not necessarily need to be included in ARTG. However, the quality and application of the evidence will be taken into consideration by TGA, if they have existing market approvals from other government bodies.
Since TGA has released the clinical evidence guidelines for medical devices and the requirements for certain types of medical devices for manufacturers when engaging in the clinical evaluation, the following represent a few of the included examples:
• Total and partial joint prostheses
• Cardiovascular devices to promote patency or functional flow
• Implantable pulse generator systems
• Heart valve replacements using a prosthetic valve
• Supportive Devices - Meshes, Patches and Tissue Adhesives
In conclusion, the guideline is designed to meet a common ground for both the industry and the regulator, in order to support the sponsors and manufacturers when collecting and presenting the clinical evidence in a way that aligns with TGA's approach on how clinical evidence are being reviewed.