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CE Mark

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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?

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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/

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Oct 21, 2022

Oct 21, 2022

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