If you want to put a medical device which is already marketed in an EU country on the market in another EU country not intended by the manufacturer this is a parallel import.
This is general guidance and is not a definitive statement of the law. If you are unsure of your position you should seek legal advice.
Once a device has been CE- marked, it can be marketed anywhere in the EU, as long as the requirements set out in the relevant Medical Devices Directives have been met. See European Commission guidance for more information about the requirements.
Parallel importer as manufacturer
As a parallel importer, you would not normally be regarded as the manufacturer of the device unless:
you repackage the product and rebrand it, so that the product is put on the market under your own name
you make changes which mean that the device is no longer covered by the original CE mark, for example you modify the device in some way, or you change the manufacturer’s lot or brand number
If you become the manufacturer, the device would need to go through a new conformity assessment procedure before it could be CE marked and put on the market in the EU.
You will not be treated as the manufacturer of a device if:
- you make changes to the language of the packaging, label and instructions for use.
- you change the size of the packaging
- the original condition of the product inside the packaging is not affected
- the change is necessary to market the product l in the UK under the same conditions as an equivalent product distributed by the original company
- you add your own name and address to the packaging to identify yourself as the parallel importer
As a parallel importer, you still have certain obligations. You should not supply the device unless it meets the essential requirements of the relevant directive. You should also not supply the device unless the device, its packaging and its instructions for use are properly CE marked and accompanied by the relevant notified body number.
Self-test in vitro diagnostic (IVD) devices
The guidance above applies to all types of medical devices apart from self-test in vitro diagnostic (IVD) devices.
The IVD Directive states that self-test IVDs must be labelled in the language of the member state of the final user. If you change the language of the labelling so that it can go on the market in a country that is different from the country it was manufactured for, you are considered to be undertaking that the conformity assessment of the manufacturer is unchanged.
This is an interim procedure until the proposed European regulation revising the Medical Devices Directives comes in to force in 2017.