Australia – TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.

“[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due to COVID-19 and the limitations on the current number of notified bodies designated under [MDR],” TGA writes.

TGA notes that the guidance applies to both international and Australian conformity assessment documents (CADs).

“Where a CAD has lapsed (that is, has expired solely because of passage of time and not because of regulatory action), this will not result in automatic cancellation of a device entry in the [Australian Register of Therapeutic Goods] ARTG,” TGA explains…