Declaration of Conformity for UKCA

Philip B

Quite Involved in Discussions
#1
Has anyone submitted a D of C under UKCA yet? The gov.uk guidance says to list UK designated standards in the declaration; the designated standards list contains out of date standards eg 14971:2012. Strictly following the guidance we would list such out of date standards in the declaration but I've been separately advised to list the newer versions. Any suggestions?
 
Elsmar Forum Sponsor
#3
I'm facing a similar problem. I'm currently reviewing labelling and IFU requirements and it l'm quite confused, as I would instinctively use the latest published standards for this matter, which are:

ISO 20417:2021. Medical devices — Information to be supplied by the manufacturer
BS EN ISO 15223-1:2021 Medical devices. Symbols to be used with information to be supplied by the manufacturer - General requirements

However, the list of UK designated standards only mentions:

EN 1041:2008 Information supplied by the manufacturer of medical devices.
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.

So, are you guys sticking to the obsolete versions listed by gov.uk?
 

Philip B

Quite Involved in Discussions
#4
I'm facing a similar problem. I'm currently reviewing labelling and IFU requirements and it l'm quite confused, as I would instinctively use the latest published standards for this matter, which are:

ISO 20417:2021. Medical devices — Information to be supplied by the manufacturer
BS EN ISO 15223-1:2021 Medical devices. Symbols to be used with information to be supplied by the manufacturer - General requirements

However, the list of UK designated standards only mentions:

EN 1041:2008 Information supplied by the manufacturer of medical devices.
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.

So, are you guys sticking to the obsolete versions listed by gov.uk?
I think I'm going to go with the versions listed in the UK designated standards as this seems to be the letter of the law. All a complete nonsense of course, as other parts of our technical documentation (eg essential requirements) will cite the latest versions. We'll see what our NB thinks when we submit, no doubt whichever way we do it will be wrong...
 

Trebor123

Involved In Discussions
#5
I have contacted our suppliers in Europe and have received a very mixed response !! Some are going to follow the guidelines and apply UKCA, some have said that they are not going pursue this and I presume not sell into the UK now as the product wont now conform (without labelling requirements); and some have said that this doesn't apply to them and are still going to send products to the UK regardless !!! So a mixed review !!! My question is though who is actually going to "police" this as my discussions with the government business units covering this area don't really have a clue and I was passed to 6 different people and still didn't get a definitive answer !! Is it going to be a case of a "paper-chase ! Are we being expected to place the UKCA sticker or label on ourselves to the products? Will customs stop container loads of products with NO UKCA LABELS - especially from China? Any HELP please much appreciated :bigwave::deadhorse:
 

Philip B

Quite Involved in Discussions
#6
I have contacted our suppliers in Europe and have received a very mixed response !! Some are going to follow the guidelines and apply UKCA, some have said that they are not going pursue this and I presume not sell into the UK now as the product wont now conform (without labelling requirements); and some have said that this doesn't apply to them and are still going to send products to the UK regardless !!! So a mixed review !!! My question is though who is actually going to "police" this as my discussions with the government business units covering this area don't really have a clue and I was passed to 6 different people and still didn't get a definitive answer !! Is it going to be a case of a "paper-chase ! Are we being expected to place the UKCA sticker or label on ourselves to the products? Will customs stop container loads of products with NO UKCA LABELS - especially from China? Any HELP please much appreciated :bigwave::deadhorse:
Are your products CE marked? If so, the CE mark will be recognised in the UK until June 2023. After this you will have to apply the UKCA mark. Have you appointed a UK approved person? You need this if you are exporting to the UK.
 
#7
Our position is:
We are UK based virtual manufacturer of pregnancy and ovulation tests. we have applied for UKCA and expect to have this in May 2022. Therefore we should be able to be fully compliant with these products in time for the change over end of June 2023.
We are also a distributor of Pregnancy and ovulation tests and Medical devices. For these products our brand name appears on pack but the OEM takes responsibility as the manufacturer. The manufacturers of these items are based in China or Europe and so far none of them appear to have done anything about complying with UKCA despite us pushing them for the last 12 months.
It seems to me that we may be in a position where we will be unable to supply most of our distributed by products from end of June next year. From conversations with other people in the industry we do not seem to be alone.
I am surprised that there is not much noise about this situation on here.
 
#8
May I ask if people are listing these standards on their DoC, or referring to the UK version of the essential requirements in the Technical File? I do not see a requirement to list out these standards on the DoC (please correct if I am wrong). Just wondering what other people are doing.
 
#9
Hi

We have submitted this statement to our UKCA NB. Note this is for IVD's.

have been and are in conformity with the essential requirements and provisions of Part IV of the Medical Devices Regulations 2002 (SI 618) as subsequently amended by the UK exit regulations of 2019 (SI 791) and 2020 (SI 1478) for in–vitro diagnostic medical devices for IVD’s which are for self-testing and are in conformity with the national standards transposing harmonised standards EN13532:2002, EN13612:2002, ISO 23640:2015, EN13975:2003, EN 13641: 2002, EN ISO 14971:2012, EN ISO 15223:2016, and EN ISO 13485:2016.
and are subject to the procedure set out in PART V (Notified Bodies, Conformity Assessment Bodies and Marking of Products) of the UK MDR 2002
under the supervision of Notified Body Number 0086,
BSI Assurance UK Ltd
Kitemark Court Davy Avenue Knowlhill,
Milton Keynes, MK5 8PP,
United Kingdom

It is not yet approved but I know it has been scrutinised by them some time ago and no comment has been made.

Hope this helps
 

WAQAR-QMS

Medical Devices Expert
#10
Don't need to be afraid.
If you are seeking list like in CE i.e. Applied standard list; answer is not necessary.
I had submitted many cases to MHRA, and it works well with them.
if you are referring to UKCA approved bodies i.e. BSI and SGS and then referencing to Technical Documentation; i suggest you should add that.
 
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