On March 6, 2019, the Australian Regulatory Authority TGA (Therapeutic Goods Administration) launched a proposal for the classification of active implantable Medical Devices (AIMD) and the reclassification of their non-implantable accessories, of active devices intended to control, monitor or influence the performance of an AIMD and of software that drives or affects the use of an AIMD in Class III Medical Devices.

TGA proposes reclassification of active implantable Medical Devices (AIMD) and related accessories in Australia

The aforementioned document incorporates the strictest classification introduced by the European MDR (EU) 2017/745. In fact, the MDR includes several amendments to the classification rules for some categories of Medical Devices to higher risk classes.

In line with the Rules 8 and 9 of classification of the MDR, TGA proposes the reclassification of devices such as: pacemakers and implantable cardiac accessories, implantable cardioverter defibrillators (ICD) and related accessories, and cochlear implants.

Being part of a series of five distinct medical device classification proposals launched on the same day, the document is currently under consultation until 29 April 2019.