Update from Regulatory Affairs Committee 31 March 2021

Update from Regulatory Affairs Committee:

• RAC members were briefed on the recent Reg Tech meeting in relation to the reclassification of Medical Devices, Adverse Event reporting timelines, Orthopaedic Loan Kits, clarification on off-label use of approved products, impact of EU MDR related changes, and exemptions from PIC/PIL;
• RAC members were asked to respond to the TGA’s questions in relation to UDIs, responses are being compiled and will be sent to the TGA by the deadline;
• Discussion of EU MDR changes, responses are being compiled to be discussed during the workshop;
• RAC asked to participate in the TGA Digital Transformation Workshop.