Hello Mike,
So, once the CE mark is not recognized, the device is non-compliant, so for a non-medical device, it would require a UKCA mark if it will still be in the market after 01/01/2022. For Medical Devices, it is 01st July 2023, to comply with the UKCA mark.
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Jay Pathak
Regulatory Affairs Specialist
Salt Lake City UT
United States
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Original Message:
Sent: 15-Jan-2021 03:21
From: Mike Kilkelly
Subject: UKCA mark
Thank you Jay,
That is indeed the case i.e. CE mark is not valid after 01 Jan 2022 but the question arises for devices that will have been brought into the UK (into a 3rd party warehouse) under CE mark in say Nov 2021 or Dec 2021 and whether they need to be UKCA marked.
regards
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Mike Kilkelly
Quality & Regulatory Affairs Manager
Galway
Ireland
Original Message:
Sent: 12-Jan-2021 11:30
From: Jay Pathak
Subject: UKCA mark
Hello Anon,
According to the guidance for Medical Devices, CE marking will be recognized until 30 June 2023 after that the certificate is not valid which means the product CE mark is not valid. After that, all the placed products will require UKCA. In my opinion, it will be the same for your product, after 01 January 2022, the CE will not be valid. Hope this helps.
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Jay Pathak
Regulatory Affairs Specialist
Salt Lake City UT
United States
Original Message:
Sent: 12-Jan-2021 03:57
From: Anonymous Member
Subject: UKCA mark
This message was posted by a user wishing to remain anonymous
Our products (non-medical) are currently CE marked. They are manufactured in China and shipped in bulk to a warehouse in the UK for onward fulfillment of customer orders in the UK .
We understand that there is now a UKCA marking requirement for selling these products in the UK . The UKCA marking came into effect on 01 Jan 2021, however, to allow business' time to adjust there is an exemption to continue to sell CE marked product until 01 Jan 2022. UKCA marking will be required after 01 Jan 2022.
My question is whether product that was placed in our warehouse before 01 Jan 2022 will require UKCA mark. I think this depends on definition of "placing on the market".
I would be very grateful for any help with this.