Parallel imports

What is Parallel Importing?
1. 'Parallel importing' describes the situation where a medical device placed on the market of one member state is marketed in another part of the Community by a parallel importer. We have received a number of queries with regard to the legality of parallel importing and the obligations of parallel importers. We are therefore setting out how we see the regulatory regime applying in this area. This guidance is of a general nature only and cannot be taken to be a definitive statement of the law. Where there is any doubt, you should always seek your own legal advice.

Regulation of Medical Devices Generally
2. Medical devices are regulated by three EC Directives: 90/385/EEC (active implantable devices), 93/42/EEC (general devices) and 98/79/EC (in vitro diagnostic devices). The obligations under these Directives are implemented into UK law by the Medical Devices Regulations 2002. The UK competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA) and it has responsibility for complying with the UK’s obligations under the Directives and for enforcing the provisions of the Regulations.

3. Once a device has been properly CE marked, it can be marketed anywhere in the Community, provided that the essential requirements set out in the relevant Directive are met. It is only open to member states to inhibit the free movement of a medical device if the relevant regulatory requirements have not been met, or if there is a health concern.

4. We should emphasise that the MHRA’s responsibilities relate exclusively to the scheme established by the Medical Devices Directives. The MHRA has no remit to deal with other issues which can arise in the context of parallel distribution, such as trade mark issues or questions of product liability.

Parallel Importer as Manufacturer
5. Normally, a parallel importer would not be regarded as the manufacturer of the device which he is importing. However, there are circumstances where a parallel importer may be treated as the manufacturer of the device which he is importing. This will be the case if:

(i) the parallel importer repackages the product and rebrands it, so that the product is placed on the market under his own name; or
(ii) the parallel importer makes changes to the device which mean that it should no longer be covered by the CE mark of the original imported device, for example, he modifies the device in some way, or he changes the manufacturer’s lot or brand number.

6. A parallel importer will not be treated as the manufacturer of a device in the following circumstances1:

(a) Where he makes changes to the language of the packaging, label and instructions for use.
(b) Where he makes changes to the size of the packaging, but only if –

(i) the original condition of the product inside the packaging is not affected; and
(ii) the change is strictly necessary to market the product distributed in parallel in the UK under the same conditions as an equivalent product distributed by the originator company.

(c) Where he adds his own name and address to the packaging to identify himself as the parallel distributor.

7. If a parallel importer is to be treated as a manufacturer, the device would need to be the subject of a new conformity assessment procedure before it could be CE marked and then marketed.

8. Even where a parallel importer does not fall to be treated as a manufacturer, he will still have certain obligations. These include not supplying the device unless it meets the essential requirements of the relevant Directive which applies, and not supplying the device unless the device, its packaging and its instructions for use are properly CE marked and accompanied by any relevant notified body number.

9. Any queries regarding this document should be addressed to:

David Batten
Medicines and Healthcare products Regulatory Agency (MHRA)
8th Floor
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel : +44 (0) 20 7084 3254
Fax : +44 (0) 20 7084 3112
E-mail : david.batten@mhra.gsi.gov.uk

1 (a) and (b) follow guidance given by the European Commission with regard to the parallel importing of centrally authorised medicinal products (O.J. No. C229, 22.7.98, pp8 –9). We believe that similar principles ought to apply by analogy to medical devices.