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QMS & CE Mark requirements for an EU Market Distributor/Trader

T

Tiffany

#1
#1
Hi Mates,

We always talk about the importer should have obtain the CE Mark if the products is place in the EU market.

I have a situation where we suppplied the products to our distributor/ trader in EU and do they need the Quality Management System and CE Mark Scheme?

Tiffany :bonk:
 
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rob73

rob73

looking for answers
#2
#2
Tiffany
If the person you refer to is only distributing the product then your distributor needs only to have a decent quality system (ISO 9001), although I do not think this is mandatory :confused: , for piece of mind I would insist that they did have a robust tracking system for products they do sell.
On the other hand, as you are outside of the EU, you must have an authorised representative to place the product on the market, will the distributor be acting as the authorised representative as well? If so there are other requirements to be met.
Rob
 
M

MIREGMGR

#3
#3
Tiffany said:
We always talk about the importer should have obtain the CE Mark if the products is place in the EU market.
Click to expand...
I'm not sure what's being described here. It's common for a device's maker to be regulatorily responsible for that device, and therefore to apply their CE Mark. In that case, the distributor...who may be the importer if the maker is located outside EU...would not apply a CE Mark.

If a maker does not have a CE Certificate and sells to a "distributor" that applies their own CE Mark, then the "distributor" is actually the regulatorily responsible party for that device.
 
T

Tiffany

#4
#4
Hi mates,

Put it in a clearer picture, we are the medical devices manufacturer outside of EU and we have appointed a EC rep within EU. Our EC rep is also playing the role as our distributor. From the aspect of the regulations in EU, is our EC Rep required to be certified for the QMS (ISO 9001 and ISO 13485)?
Is this a mandate requirements in EU?

Thanks.... :thanx:

Tiff
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#5
#5
MIREGMGR said:
If a maker does not have a CE Certificate and sells to a "distributor" that applies their own CE Mark, then the "distributor" is actually the regulatorily responsible party for that device.
Click to expand...
I think what you describe is a delicate situation. Basically, selling a medical device to an EC-based entity and shipping the goods over (by a foreign entity), is placing on the EC market -- which shouldn't be done without properly CE marking first. As far as I understand it doesn't matter even if the above EC-based entity is a sole importer and the foreign entity doesn't otherwise do any distribution in/into the EC.

If, on the other hand, the act of sale AND the physical transfer of ownership/responsibility occur outside the EC, and then the EC-based entity physically transfers the device into the EC, the foreign entity may not need to CE mark. It'd then be totally up to the EC distributor/importer to do that.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#6
#6
Tiffany said:
Hi mates,

Put it in a clearer picture, we are the medical devices manufacturer outside of EU and we have appointed a EC rep within EU. Our EC rep is also playing the role as our distributor. From the aspect of the regulations in EU, is our EC Rep required to be certified for the QMS (ISO 9001 and ISO 13485)?
Is this a mandate requirements in EU?

Thanks.... :thanx:

Tiff
Click to expand...
Short answer: No.

Mind you, the distributor (EC rep in your case) would have some obligations regarding post-marketing surveillance / vigilance / customer complaints / adverse events reporting etc. and traceability for recall / field correction purposes.
 
M

macwilliams

#7
#7
Hi
Yes,you are right.If you are importing a boat from USA or non European country then you have to ensure that your boat is CE marked.
 
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