Technical CE file for medical devices

Technical file for medical devices

In this file you will find the following documents:

• Legal framework (coat rack document)
• Risk analysis (Medical Devices Regulation (EU) 2017/745)
• What should be included in a user manual as a minimum?
• Is the intervention of a Notified Body necessary?
• What should be on the CE label?
• (EU) Declaration of Conformity

An online course explaining the file is also available for this file.

If desired, you can also complete the course with a test after which a certificate will be issued.

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