This message was posted by a user wishing to remain anonymous
Hello again,
One more question - When updating the CER, we are just focusing mostly on the extension tube since that's what has been added to the product family which initiates this update to the Tech file as well as the CER.
Now my question is that do we have to include the previous CER data again on the connector since our initial CER already covers that and it would be redundant to have that information in the update. Also, the literature search gap analysis will be for a year and that will not provide us any new information to add.
My understanding is that we are just updating the extension tube to our product family, the point of this CER update would be to consider safety and risk factors of the extension to the intended use. Is that correct?
Any suggestion/advise/information is appreciated. Thanks!
Original Message:
Sent: 04-Feb-2020 04:34
From: Richard Vincins
Subject: CER update
Yes, I would imagine you would also be updating your Technical Documentation file at the same time with the extra product codes/part numbers of the extension. Whether it is an accessory or not, just keep in mind the justification for including this all together in a "product family" as it related to technical documentation and clinical evaluation. If there is a reason these extension tubes should have their own Technical Documentation file or a reason they should be included all together; just make sure you can answer reasoning for putting them all together.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 31-Jan-2020 17:22
From: Anonymous Member
Subject: CER update
This message was posted by a user wishing to remain anonymous
What happens to the tech file? Do we also update the current tech file or create a new one?
Thanks!
Original Message:
Sent: 31-Jan-2020 08:48
From: Richard Vincins
Subject: CER update
I have worked on something similar, we just updated the existing CER. However, we did run all the gather and data analysis including the additional product codes such as in your case the extension tube. You would want to make sure any assessment is done now with inclusion of the extension tubes/connectors for impact on safety and/or performance including State of the Art such as how these extension tubes or other accessories impact clinical use of the device.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 30-Jan-2020 15:56
From: Anonymous Member
Subject: CER update
This message was posted by a user wishing to remain anonymous
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!