Time is running out to qualify for the EU MDR transition extension as per the regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746.
Manufacturers must apply for MDR certification with an MDR notified body by 26 May 2024 and before their MDD certificate expires.
For new TGA ARTG entries, evidence must be submitted as part of the application.
Contact us for more information.