Following a decision by the European Commission to implement a number of medical device reforms, including to up-classify all surgical mesh medical devices (such as gynaecological mesh) to Class III and to provide patient implant cards and consumer product information for all implantable medical devices, the TGA is looking at undertaking the same measures.
This action is in line with a decision by the Australian Government in September 2016 on the Expert Review of Medicines and Medical Devices Regulation. One of the recommendations was to align, wherever possible, the Australian regulatory framework with the European Commission in respect of the Classification of medical devices.
The TGA has released a consultation paper that is seeking comments on two measures to further align Australian and European medical device regulatory requirements:
- Reclassification of all implantable surgical mesh medical devices from a Class IIb (medium to high risk) to Class III (high risk); and
- Introduction of formal requirements for medical device manufacturers to provide patient implant cards and product information for all active and implantable medical devices.
The TGA is looking for views from industry, healthcare professionals, and current and future recipients of medical devices on the proposed implementation approach for these changes. Comments will assist the TGA to identify issues, and address any unintended consequences, to inform the proposals and the regulatory amendment process.
Interested parties should respond by close of business Friday, 25 August 2017. For more information visit the TGA website.