Can a Distributor Apply for Registration of a Product in the EU

[MIREGMGR]

I hope you were not implying I said any of the above, because I didn't.

That comment was by comparison to some of the US FDA's internal machinations in regard to other countrys' regulatory systems. It's well known, I think, that a traditionalist faction within FDA doesn't favor harmonization and the GHTF efforts of certain CDRH personnel, and therefore has a certain attitude regarding EC directives and related standards.

 

[drewsky1]

Thank you for your insight on this. At this time, we will only be the distributor, not the manufacturer. My interest is in how a distributor register for a product in EU and Internationally where the original manufacturer will continue to produce the product. Currently, we don't intend to be the manufacturer but that may come down the road. If that did occur, I would imagine both our companies would need to modify the contract we curently have with them. How would the registration process for a product in EU differ if one is a distributor or a manufacturer?

 

[pkost]

As a distributor in the EU, you don't need to register anything; all you have to do is assure yourself that the product is appropriately CE marked, you are then able to sell the device.

As a manufacturer, with the exception of Italy you don't have to register individual products either, the device just has to be CE marked. For class I's this is done by informing the local competent authority (I don't know how this works for non EU manufacturers) and self certifying. For all others with a review of the technical file/design file by a notified body.

Italy is an exception in that they require devices to be registered (there is a another thread for this on the forums). I don't know how it works/what is involved or even why the EU has not put a stop to it.

 

[MIREGMGR]

At this time, we will only be the distributor, not the manufacturer.

The EU does not provide a mechanism for a distributor to add the CE Mark to a product that is not CE Marked by its OEM Manufacturer. At the least, you would have to become the product's Private Label Manufacturer and take on a share of the regulatory responsibility for the product, to get it CE Marked.

If you have the product labeled with your name as the distributor, but with the Manufacturer symbol indicating the OEM Manufacturer, then the CE Mark on the product must be the OEM Manufacturer's.

(I don't know how this works for non EU manufacturers)

When a device is marketed in Europe and its regulatorily responsible manufacturer is located outside Europe, that regulatorily responsible manufacturer must have an Authorized Representative that is physically located and appropriately registered in Europe. The device's label must identify this Authorized Representative via the EC REP symbol. The Authorized Representative, not the US company, handles the direct interface with the EC via the CB of the country in which they are located.

Note that a Distributor cannot have an Authorized Representative. The Authorized Representative relationship must be with the company that is responsible for the CE Mark.

 

[pkost]

When a device is marketed in Europe and its regulatorily responsible manufacturer is located outside Europe, that regulatorily responsible manufacturer must have an Authorized Representative that is physically located and appropriately registered in Europe. The device's label must identify this Authorized Representative via the EC REP symbol. The Authorized Representative, not the US company, handles the direct interface with the EC via the CB of the country in which they are located.

Ah, I know about the EC rep, but it slipped my mind that they would register and therefore use their CA!