TUV Rheinland, our notified body, has provided a letter confirming the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 as regards the transitional provisions for certain medical devices.
The full letter is attached below. If you have any questions, please contact Ashley Sanchez: ashley.s@oc-orthodontics.com
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