UKCA

[Manel Mou]

PLEASE I need your opinion on the following:
for EU manufacturer selling products in EU+UK, can we affix UKCA+CE MARK on the same packaging?I mean, is the UKCA MARK and UK Responsible Person details mention on the packaging accepted in EU?

THANKS FOR YOUR HELP.

 

[Zero_yield]

My understanding is that you can have both on the same packaging / label. I'm checking to see if I can find objective evidence of that.

 

[Zero_yield]

Regulating medical devices in the UK

Labelling requirements
You must ensure that your device meets EU labelling requirements in order to place it on the EU market. Both the CE marking and UKCA marking can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Devices placed on the Northern Ireland market must meet EU labelling requirements.

So at least the UK will accept product with the UKCA mark AND CE mark. Haven't found a source on the EU side yet.

 

[Zero_yield]

A product may bear additional markings and marks, provided that they fulfil a different function from that of the CE marking, are not liable to cause confusion with it, and do not reduce its legibility and visibility.

In this respect, other markings additional to the CE marking need to fulfil a different function from that of the CE marking. Thus, they should provide information on conformity with objectives that are different from those to which the CE marking relates (for example environmental aspects not covered by the applicable Union harmonisation legislation).

EUR-Lex - 52016XC0726(02) - EN - EUR-Lex

 

[Manel Mou]

EUR-Lex - 52016XC0726(02) - EN - EUR-Lex

THANK you for your helpful information

 

[Philip B]

We place both the CE mark and the UKCA mark on our labels and these have been approved by our NB for both UK and EU applications.