TGA to Lift Extra Scrutiny of EU Device Notified Bodies

Australia’s Therapeutic Goods Administration will loosen its oversight of certain notified bodies, the agency announced last week.

The move comes after a TGA assessment decided increased oversight of the bodies in the European Union had satisfied earlier concerns about the dependability of assessments for medical devices.

The TGA implemented the heightened scrutiny in 2014 for eight European institutions after a British Medical Journal investigation indicated the bodies had based decisions on minimal evidence of safety and efficacy for high-risk devices.

Based on the EU’s reforms, the agency decided to reduce its scrutiny. The EU de-designated some of the notified bodies while redefining the designations of others.

“As a result of the added scrutiny of notified bodies that has recently occurred in Europe … the TGA no longer considers it necessary to apply these increased audit requirements,” the agency said.