You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.
For a clinical investigation device, only in the define sites for the investigation.
For a clinical investigation device, in patients, obviously.
Before importing. You need to draw up a CE marking for the device, contact MHRA and follow it's procedure, have it's "approval" then you can import the device.
For a clinical investigation device, only in the define sites for the investigation.
For a clinical investigation device, in patients, obviously.
Before importing. You need to draw up a CE marking for the device, contact MHRA and follow it's procedure, have it's "approval" then you can import the device.
