AUSTRALIA: Effects on Australia Registrations by the EU MDR Transition – January/February 2023
- 2023-01-19 06:20:26
Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.
Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.