TGA Considers Device Regulatory Changes Amidst Notified Body Shortage

Australia’s TGA said it’s monitoring the lack of notified bodies designated under the EU’s new device and in vitro diagnostics regulations (MDR/IVDR) and may make regulatory amendments if necessary.

“The TGA is aware of industry concern should a sufficient number of notified bodies not have been designated under in the new EU MD Regulations by May 2020,” the regulator said.

The agency said that manufacturers seeking certification for new products or maintaining existing certification may be affected by notified bodies that do not intend to transition to the new MDR — such as Lloyd’s Register and QS Zurich AG — and can use overseas regulator arrangements as alternatives for conformity assessment.