Do we need to create a new CER or can we just update the existing CER

M

MDRexpert

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#1
#1
Hello Everyone,

We have a device that is a connector used in infusion therapy that goes with an extension tube. We have a CE marking for the connector and learnt that we can add the extension tube to the existing product family. The connector is by default used with this extension tube (please keep in mind it is not an accessory, its a device). Our company has decided to add this extension set (new part number) to our current submission which brings a lot of updates one of which is the CER. Do we need to create a new CER or can we just update the existing CER with the updated part numbers?
None of the following changes due to this update:
  • Indications
  • Contraindications
  • Adverse Events
  • Design change – none. The design and material of the extension tube is exactly the same as our proposed equivalent device so its easier to prove equivalence.
  • We may consider additional benefit/risk assessment associated to ensure conformity.
  • We will also perform a gap analysis on the RMR, PMS, literature search and the state of the Art.
Please advise.

Thank you!
 
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SKM.Sunil

SKM.Sunil

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#2
#2
You can update the current CER with additional data of the device family. As the device class is low, it can also comply guidelines.
 
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