Hello, I was hoping someone could advise me on an issue with CE from a complaince perspective.
A manufacturer I use has a valid CE certificate until the end of June 2022, they have told me the renewal is going thorugh, but due to new laws it is more complicated and they may not be able to obtai the renewal until the end of July. But they are sure there will be no issue.
I have two questions:
1 - Bewtween the end of June and when they get the renewal, can I sell the products I hold that were manufactured under a valid CE, even though it will be out of date?
2 - If I purchase new products that have been produced without a valid CE, they will not be compliant will they?
Thank you
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
May 31, 2022
1 - Bewtween the end of June and when they get the renewal, can I sell the products I hold that were manufactured under a valid CE, even though they will be out of date?For all medical devices that are produced until the expiry date of the MDD certificate, you can sell until the expiry date of the device.
2 - If I purchase new products that have been produced without a valid CE, they will not be compliant will they?The manufacturer is not allowed to produce the device anymore after the expired certificate.
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May 31, 2022
May 31, 2022