Expert Advice Community

Guest

CE Mark

  Quote
Guest
Guest user Created:   Oct 21, 2022 Last commented:   Oct 21, 2022

CE Mark

We would like to inquire after regulations / requirements needed for a patient controlled analgesia pump. Is there a guideline that needs to be followed or adhered to in order to get the CE mark on a product?

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 21, 2022

For the European market, all medical devices must be in compliance with Medical device regulation MDR 2017/745.  In this document, all relevant information is what needs to be prepared to get the CE mark.

You can find the MDR in full text on the following link: https://advisera.com/13485academy/mdr/

Also, you can find a lot of supporting reading material in our ISO 13485Academy on the following link: https://advisera.com/13485academy/free-downloads/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 21, 2022

Oct 21, 2022