The MDR certification process involves the following steps:
Source: https://www.emergobyul.com
EUDAMED is a database that will be used to track the safety and performance of medical devices in accordance with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). EUDAMED, or the European database for medical devices, is a key component of Europe’s new medical device and IVD regulations.
Source: https://www.emergobyul.com
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