【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean?
May 16, 2024
Source: drugdu
158
Drugdu.com expert's response:
The 4-digit number next to the CE mark on medical devices indicates the Notified Body identification number (or Module D number). These digits identify the Notified Body that has certified the device's quality management system. It signifies the registration number of the certifying body, indicating that it has assessed the quality management system of the medical device and confirmed its compliance with the relevant European Union directive requirements. This number is crucial for tracking the validity of the certification and for regulatory purposes.
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