Brexit Mandate for EU Authorised Representative for non medical devices

#1
I work for a UK based company that exports a lot of electronic measurement equipment into the EU. Under the new market surveillance and compliance directive and as the UK is no longer in the EU, we need to appoint an authorised representative based in the EU to represent us to cover EU compliance issues before July this year. We have a registered company based in Spain whom we intend to use as the representative but understand we need to draw up an official mandate to appoint that office as our representative.

I cannot find any examples of the required contents of the mandate and list of responsibilities on the EU or other websites that is specific to this directive. I can find lots of information and guidance for the Medical Devices Regulations directive but I believe the responsibilities for market surveillance directive are not so onerous, so am looking to see if anyone has a template or an example of a mandate for this type of mandate, please? Just to state our products are not covered by the MDR or the machineries directives.

We are hoping to make our Spanish company simply a contact point so they can bounce any information requests or complaints to the compliance experts in our office, however I know they will still be legally responsible for the compliance so we need the correct legal documentation.

Has anyone drawn up such documentation they can share please?
 
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CharlieUK

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#2
An Authorised Representative (AR) isn't mandatory as per Recital 18:

The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union.

You're Spanish office can be the "importer" -they don't actually have to import anything, but have to ensure that their name and address is on the product and/or packaging as required.

Whoever imports your products into the EU from UK becomes "The importer" , and to keep it simple and "in house" the easiest option is to have an EU address for CE marking and a UK address for UKCA
 
#3
Yes agreed, but the general advice I have read is that the authorised rep route is simplest if you sell into multiple EU countries with some sales also being made directly from the UK and some going through other resellers. We will of course put the name of the Spanish Office on the packaging as being the authorised rep but we don't want them to be dragged into import issues (of which there are some!) for goods being shipped to other EU countries. Whichever way we go I still think we need a legal mandate for them to represent us for EU compliance though?
 

CharlieUK

Quite Involved in Discussions
#4
Don't forget, before the UK left the EU you didn't need a legal "importer" every time you shipped into a different EU country from the UK

Only Authorised Representatives need Legal Mandates - Importers don't

The "Importer" is an Economic Operator who places product on the market from a 3rd Country (which now includes UK)
 
#5
Hi, sorry to jump in.
I just read in the blue guide that, the requirement for manufacturer (and importer):

"The address must indicate a single point at which the manufacturer can be contacted, in particular by market surveillance authorities. The legal text obliges the manufacturer to put a single contact point on the product. Only one single contact point in each product is allowed. This is not necessarily the address where the manufacturer is actually established. This address can for example be the one of the authorised representative or of the customer services."

So if I am a manufacturer(factory) physically outside EU, but own an office in EU.
Can I show my company name(the factory outside EU) and company address (office inside EU)?
With this I can skip all the obligation from importer or appointing EC representative?

Thanks in advance!
 

CharlieUK

Quite Involved in Discussions
#6
The "manufacturer" is not the "factory", the manufacturer is the company that brands the product under their name

If you use an address for the manufacturer that is outside the EU, then the product is being placed on the market from a 3rd country, so the person doing this becomes the "importer".

If you use an address for the manufacturer that is inside the EU, the person who "imports the product" is not an "importer" as defined in the Directive

In either case, the actual factory where product is made is irrelevant for labelling
 
#7
Thanks for your reply!

Sorry for the irrelevancy about the "factory".

So, even if the manufacturer main business operation is outside EU(Manufacturer's Name:AAA, Address:BBB), once it set up a little office(Office's Name:CCC, Address:DDD)

Then in the marking, it is acceptable to just show as below:
Manufacturer name: AAA
Address: DDD

Is it correct?
With this, the importer is no longer valid.
Then must I still need to appoint an external EC rep in MDR?
Thanks again!
 
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