Wow that scenario is a tricky one - I guess first word of advice is do not let your CE Certificate get suspended - probably obvious to you of course. The definition of placing on the market by the Directive/Regulation basically is making available the product and/or distributing to end users. It is generally understood that "ownership" of the product occurs when there is a financial transaction or other non-fee based transaction, such as when persons take devices for free in the beginning for a company to gain market with a customer. In the case where product is on consignment, I would venture that there has not been an official transfer of ownership. In my thought process it does depend on whether the device is in use or has been used. As an example, there are large equipment that are on consignment or more precisely leased to a company where the user does not "own" the device, but they still use the device.
Another way to possibly think of it is when the product was placed on the market, i.e. provided to the customer under consignment, then the product had a valid CE Certificate. My understanding has been that once a CE Certificate is suspended or withdrawn, then no further placing on the market can occur, but it does not necessarily mean that all those products out in the field need to be withdrawn. If the CE cert was pulled for safety reasons, then most like this would have also resulted in a field corrective action. If the CE cert was pulled because of quality system issues, maybe it has nothing to do with the product safety and performance (though some would argue this point as well). To take some regulatory risk (higher risk) would be to state those consigned products have been placed on the market under a valid CE certificate, therefore they can remain in the market. Minimising the regulatory risk would assume that because these products while in the market are still the responsibility of the legal manufacturer would assume there would be a market withdraw to prevent further use of these products. And again, that goes without saying that if there is an issue with safety or performance related to CE certificate suspension, then a field corrective action or market withdrawal may be required.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 05-Dec-2018 17:47
From: Anonymous Member
Subject: CE Certificate Suspension - Consignment Stock
This message was posted by a user wishing to remain anonymous
In the event of a CE suspension, what are the requirements for stock placed with customers on consignment?
The products are not yet sold, but are physically with the customer to be paid for upon their use. To leave the stock with the customer on consignment may result in a sale without a valid CE cert.
Would retrieval of the product constitute a field action?
Any guidance welcomed. Thanks