Great Britain's (GB's) revised UKCA and UKRP labeling requirements are linked to when the product is "placed on the market". This may not coincide with "importing" the product. Consequently, rather than linking the labeling requirement to the "importing" of the device, it is instead required that we carefully apply GB's actual designated language / criterion, which is "placing on the market".
"Placing on the market" means the first making available of a device unit (not device type; not device model; but rather an individual device unit) for distribution, consumption or use on the
GB market as part of a commercial activity. This can be in return for payment or free of charge. This happens after a product has been fully manufactured (i.e., labeled). A product is placed on the market when an offer or agreement is made for the transfer of ownership, possession or any other property right. It does not require the physical transfer of the product. Accordingly, if we focus our conformity target (be it regarding labeling or any other conformity requirement) on "importing" of the device, then we would not be in alignment with the MHRA's current nor its upcoming regulatory requirements.
Moreover, historically, "placing on the market" hasn't been deemed to necessarily have happened upon the transfer of a device from a third country manufacturer outside GB to the manufacturer's own GB stocks/warehouse, nor to the third country manufacturer's GB authorized representative (i.e., now called the UKRP), and maybe even not to the GB importer, if the product is not yet being supplied for distribution, consumption or use. In the MHRA's recent (June 2022) response to its public consultation about its proposed new regulations, I found nothing indicating that GB would alter this longstanding principle.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 02-Feb-2023 09:37
From: RAJE DEVANATHAN
Subject: UK Responsible Person Labeling
Hi,
UK REP name and address is required to register the product on the database by the manufacturer or UK responsible person and is expected to be on the label when importing. The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed.
Thanks
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 02-Feb-2023 08:48
From: Anonymous Member
Subject: UK Responsible Person Labeling
This message was posted by a user wishing to remain anonymous
Hi all,
as you probably know. after 1 July 2024 we are required to re-label the medical devices for placemet them on Great Britatin market. UKCA mark with the number of the approved body is one of the label requirements.
Additionaly, the UK-Rep Name and Address needs also to be indicated in the labeling. The UK Guidance is saying the following:
"However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed".
So my question is, do UK-Rep data (name & address) have to be put on a product before leaving the country ? or is there an opportunity to affix an additional label locally by UK-REP?
Thanks for your support.