B
bikeshox
Hi forum members,
There is an existing thread on this topic:
Medical Device (MedDev) Vigilance Guidelines for Importers into the UE
But it is a bit old and a little different...
We are a manufacturer of Class I medical devices based in the EU. We manufacture our own "branded" product, as well as "Private labels" for various distributors/(manufacturers), and sell to OEM customers where they kit our product into their product and call it their own.
We are looking to import a particular product from outside the EU and I am looking for information regarding the requirements of the exporter and for us, the importer.
We would buy the product from the exporter and resell the product to OEM customers which they would then place in a kit.
I hope that is enough information for someone to point me in the correct place! And in advance as always, Thanks!
There is an existing thread on this topic:
Medical Device (MedDev) Vigilance Guidelines for Importers into the UE
But it is a bit old and a little different...
We are a manufacturer of Class I medical devices based in the EU. We manufacture our own "branded" product, as well as "Private labels" for various distributors/(manufacturers), and sell to OEM customers where they kit our product into their product and call it their own.
We are looking to import a particular product from outside the EU and I am looking for information regarding the requirements of the exporter and for us, the importer.
We would buy the product from the exporter and resell the product to OEM customers which they would then place in a kit.
I hope that is enough information for someone to point me in the correct place! And in advance as always, Thanks!