EUDAMED is LIVE
The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
Harmonised Standards for MDR? CEN/CENELEC say “Non”
Back in November 2019, looking at the virtual break down in harmonisation of standards to the European Directives and the belated request from the Commission for harmonisation to MDR of...
TGA expedites COVID-19 approvals, while keeping up business as usual for other devices
The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
TGA acceptance of international device reviews – clearing the fog
A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....
Are Harmonised Standards facing irrelevance?
There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR). And rightly so. But harmonisation is already in disarray...
The question on clients’ lips… “How long will my application take?”
Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, the TGA released the latest annual statistics on...
Out They Go – FDA Clears the Store of Guidances
In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
