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This message was posted by a user wishing to remain anonymous


The company I work for is currently preparing for an upcoming UKCA audit and after reviewing MHRA guidance, I wondered if anyone had experience with the requirements for record retention in the UKNI? It appears the new retention requirements may point to the EU MDR and therefore be the same? Additionally, I was curious if there are any sorts of UKCA audit checklists which could be reviewed prior to the actual audit. It seems like there is very little information available for this new required certification. In speaking with our normal network of peers, no one has scheduled their UKCA audit, so all feedback is welcome if you have experience in this audit process.

Hi There!
As per UKCA, Under technical documentation section Records Keeping, says 10years after you keep the product in the market, it can be asked for anytime by market surveillance.
https://www.gov.uk/guidance/using-the-ukca-marking

hope it helps!

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Pallavi Sharma
Florham Park NJ
United States
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Original Message:
Sent: 11-Feb-2022 08:53
From: Anonymous Member
Subject: Record Retention Requirements

This message was posted by a user wishing to remain anonymous


The company I work for is currently preparing for an upcoming UKCA audit and after reviewing MHRA guidance, I wondered if anyone had experience with the requirements for record retention in the UKNI? It appears the new retention requirements may point to the EU MDR and therefore be the same? Additionally, I was curious if there are any sorts of UKCA audit checklists which could be reviewed prior to the actual audit. It seems like there is very little information available for this new required certification. In speaking with our normal network of peers, no one has scheduled their UKCA audit, so all feedback is welcome if you have experience in this audit process.