You are here
Clinical evidence guidelines: Medical devices
The relevant Australian legislation for regulation of medical devices:
- Therapeutic Goods Act 1989 (the Act)3, particularly Chapter 44 of the Act
- Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations)5.
Medical devices are classified according to the intended purpose of the device which generally correlates with the level of risk:
- Medical devices are classified under Schedule 26 of the MD Regulations from lowest to highest risk into Classes I (which includes Im, with a measuring function and Is, supplied sterile), IIa, IIb, III and Active Implantable Medical Devices (AIMD)
- IVDs are classified under Schedule 2A7 of the MD Regulations from lowest to highest risk Classes 1 to 4.
The classification of a medical device determines the options available to the manufacturer for demonstrating compliance with regulatory requirements prior to market authorisation, and to an extent the level of review by the TGA or certification bodies (e.g. European Notified Bodies) in the conformity assessment process.
A medical device must comply with the Essential Principles9 (EPs) which set out the requirements relating to safety and performance. The Act and MD Regulations also require that the sponsor must have available sufficient information to substantiate compliance with the EPs or have procedures in place with the manufacturer that will allow them to obtain such information and provide this information to the TGA if required.
The obligation to have information that demonstrates compliance with the EPs is with the manufacturer and the sponsor must be able to provide information to demonstrate such compliance10. This applies to all medical devices regardless of risk class.
The manufacturer and sponsor must (among other matters) provide clinical evidence to demonstrate compliance of the devices with the EPs if requested11.