If you haven't already, look at this site:
https://www.gov.uk/guidance/using-the-ukca-markingI think the general rules section will be helpful to you.
Depending on the type of device you manufacture, the accompanying document might be:
Package insert
Instructions for Use (maybe included in user interface of software)
Surgical Technique Guide (used for orthopedic devices)
User Manual (maybe included in user interface of software)
After considering this list, review the list of similar types of documentation provided for your device and decide whether you should include in UKCA mark.
I haven't dug up the legislation that defines "accompanying," but perhaps another responder will.
https://www.legislation.gov.uk/uksi/2002/618/contentsJackie
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Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
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Original Message:
Sent: 01-Jun-2021 04:00
From: Mike Kilkelly
Subject: UKCA labelling requirements and meaning of "accompanying document".
Hi All,
I would like to get some guideance on what is acceptable as an "accompanying document" in relation to UKCA labelling requirements for non-medical devices (e.g. devices that need to complay with EMC Directive).
Reference www . gov.uk :
Marking is required before 1 January 2022 but "Until 1 January 2023, ...... you have the option to affix the UKCA marking on a label affixed to the product or on an accompanying document."
Will a statement in an Instruction manual (or a stand alone document) inside the packaging be acceptable (i.e not visible without opening box) ?
Is there a requirement to have a label on the outside of the box?
I would be very grateful for any information on this
regards
Mike
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Mike Kilkelly
Quality & Regulatory Affairs Manager
Bio-Medical Research Limited
Galway
Ireland
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