MedTech Europe and Mecomed have published considerations on the impact of the EU MDR and IVDR transition on international registrations in the Middle East and Africa, calling for a harmonised and risk-based approach to change management.

The TGA has updated its guidance on UDI compliance timeframes for medical devices in Australia, including clarifications on legacy devices, EU MDR transitions, consignment stock, and Surgical Loan Kits.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.