【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean?
May 16, 2024
Source: drugdu
140
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.
Copyright©2024 Ddu. All rights reserved.
Read more on
- 【EXPERT Q&A】How to check the drug registration standards? Where do you find it? November 22, 2024
- 【EXPERT Q&A】How to determine the clinical evaluation path of medical devices? November 20, 2024
- 【EXPERT Q&A】What are the requirements for naming in vitro diagnostic reagents? November 18, 2024
- 【EXPERT Q&A】What should I pay attention to when IVD uses overseas clinical trial data? November 15, 2024
- 【EXPERT Q&A】What is the concept of GMP certification? What is the connection between GMP and FDA? November 13, 2024
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
