Further to Edward's comments, I would likewise raise the question of whether a watermarked UKCA mark can pass the "visibility" / prominence test when it requires an Approved Body number (which thus complicates the appearance when overladen with other information).
But I don't believe that the UK Responsible Person (UKRP) information is considered to be part of the UKCA mark. Instead, the UKRP labeling requirement is a separate (but related) issue. Indeed, the UKRP information does not need to be affixed in direct association with, nor proximity to, the UKCA mark.
Another point for consideration is that, although the MHRA has stated that the UKCA mark may take "...
different forms (for example, the colour does not have to be solid)...", it nonetheless requires that the letters forming the UKCA marking must be in proportion to the version I've attached where the "UK" aspect is stacked on top of the "CA" aspect. Accordingly, I would personally be hesitant to stray from that UKCA mark stacked design.
You might also find useful the MHRA's relatively recent implementation guidance that provides additional easements regarding the placement of the UKCA mark.------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 21-Nov-2022 04:03
From: Edward Ball
Subject: Conformity Transition on Markings from CE to UKCA on Labels for Use as per MDR Compliance
Definitely an interesting idea John, and one maybe to pursue further. For many devices, it would also need the UK Approved Body number, and for devices from a manufacturer based outside of the UK it would need the name and details of the UK Responsible Person. Not insurmountable, but to Anne's point, it depends on how much detail could be included as a watermark whilst still passing 'acceptance criteria' for legibility and also understanding (watermark content may be perceived differently from the main label by users, but I feel less of an issue here as it would be 'regulatory' conformity information rather than information for safe use). The MHRA are supposedly setting up several working groups to help aid the final definition of the new UK regulations for medical devices etc. and so this could be a suggestion for that forum.
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Edward Ball
Manager, Intelligence & Innovation
United Kingdom
Original Message:
Sent: 17-Nov-2022 08:27
From: John Barry
Subject: Conformity Transition on Markings from CE to UKCA on Labels for Use as per MDR Compliance
Dear All,
I was wondering does anyone have a concept for the markings on UKCA labelling transition from CE marked to UKCA.
Please note I am not requesting anyone to disclose their concepts as I know how confidential the matter is however a simple Yes or No.
The reason I ask is, I understand this is a big issue for the labels to meet the MDR regulatory requirements.
I believe its an issue surrounding the entire industry, that is, having no space for marking every label type.
However this is something I believe I may possibly be able to contribute to or to throw out an idea as a minimum.
I know its very brave of me if I post my idea on the board however no harm or worries.
Thank you for reading my post.
Best Regards,
John
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John Barry
Project Engineer
Mullingar
Ireland
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