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.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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