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This section provides background on the reclassification of joint replacements and how the need for these definitions arose:
Background on up-classification of joint replacement implants
To obtain greater assurance in the safety and performance of shoulder, hip and knee joint replacement medical devices, the European Commission issued Directive 2005/50/EC (pdf,40kb). This amended the classification of the implants from Class IIb to Class III medical devices. The European Commission released further guidance in January 2007 to clarify the intention of this classification rule:
- Guidance document on directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements (pdf,33kb)
On 1 July 2012, TGA amended the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) to align the classification of these devices in Australia with European Union arrangements, and to provide for a parallel level of rigour of premarket assessment of these joint replacement medical devices.
The TGA provided a two year transition period for sponsors of existing Class IIb Australian Register of Therapeutic Goods (ARTG) entries to apply to up-classify their devices. In April 2014 this transition period was extended by 12 months, from 30 June 2014 until 30 June 2015.
The need for definitions
As the reclassification transition period progressed it became apparent that there were differences in interpretation of the classification rules within the Europe Union. Many manufacturers reply on European certification to support market entry in Australia. Given this it was agreed greater clarity was needed on which medical devices are joint replacements and so classified as Class lll medical devices under Australian regulations, and which devices act as ancillary devices to the joint replacement and are Class llb medical devices.
The transition period was extended in part to allow development of a definition of shoulder, hip and knee joint replacement medical devices and ancillary medical devices.