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Selling a product in Both UK and EU after Brexit

dinaroxentool

dinaroxentool

Registered
#1
#1
Hello everybody. I have a question, the reason for it is saving costs. There is a product that is intended to be sold in both UK and EU. Given that the label is compliant to both the MDR and the UK Medical Device Regulation. Do you know if you can have a CE Mark and a UKCA mark together on the same label, as well as all the information required for both regulations, or you should have a batch of products for the EU with the CE mark and a batch of products with the UKCA mark for the UK? The product is a Class I medical device, the manufacturer is in Europe and it has a UK Authorized representative. Thanks :)
 
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Steve M

Starting to get Involved
#5
#5
We are planning to use both CE and UKCA mark as the MHRA have said that both will be accepted even after 30 June 2023 which is also mentioned in the link provided by @dgrainger. It is just that a solely CE-marked product will not be acceptable after 30 June 2023 I believe.
 
U

ugecha

Starting to get Involved
#7
#7
Hello everyone. I have some questions about Record Keeping for UKCA technical file.
The Guidance (Using the UKCA marking), Using the UKCA marking says,

The information you must keep will vary depending on the specific legislation relevant to your product. You must keep general records of:

1. how the product is designed and manufactured
2. how the product has been shown to conform to the relevant requirements
3. the addresses of the manufacturer and any storage facilities

Q1 for 1 and 2 above
We want single technical file covering both CE marking and UKCA marking.
I think above 1 and 2 are the same as those contained in the CE technical file. So which means as long as you have a complete CE technical file, we don’t need any additional contents. Am I right?
Or is there anything we should add something else in the UKCA technical file?
If you know places to learn what exactly are required for the UKCA T technical file, will you please let me know, thank you.

Q2 for 3 above - “the manufacturer”
Could you tell me what “the manufacturer” is?
Does “the manufacturer” mean so called the legal manufacturer holding the EC certificate?
OR factories who make actual products?

Q3 for 3 above - “any storage facilities”,
Regarding “any storage facilities”, our factory makes products and store in their warehouse until orders arrive. When ordered, the factory sends products to importers in Europe and they store products in their places.
So, in this case, does “any storage facilities” mean our factory’s warehouse and the importer’s storage places?

I’d appreciated your advice.
 
P

Philip B

Involved In Discussions
#8
#8
Our NB has told us that gaining the UKCA mark will be very straightforward and inexpensive once we have transitioned to the MDR. We are reading into this that the technical file and QMS requirements for the UKCA mark will be very similar if not identical to the EU CE mark. Best to check with your NB though. Normally when we ask our NB a question the answer is 'send us a load of money'...
 
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