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Parallel imports of medical devices: changes introduced by the new Regulation 2017/745 (MDR)

Parallel imports of medical devices is a concept transferred de facto to the medical sector from the pharmaceutical one. The underlying activity is given by the placing on the market of medical devices by a third party different from the legal manufacturer on the Member State territory (importing country) where the legal manufacturer has already placed on the market the medical devices.

This is usually possible when the third party purchases the manufacturer devices in another Member State (exporting country), where as well the devices have already been placed on the market by the manufacturer.

The concept of parallel imports, when placed in the context of the regulatory framework related to medical devices (old Directive 93/42/EEC or MDD), is not perfectly suitable, given that the third party would not qualify as importer but rather as distributor: the medical devices from the legal manufacturer are already placed on the market both in the importing and exporting countries, both as well Member States inside the Union. The old MDD does not address directly such a situation.

The mere role of the importer is mentioned only once in point 13.3(a) of Annex I, where it is given for granted that the device is entering the Union market from an extra-EU manufacturer and thus in presence of an established authorized representative. Such incidental deregulation has allowed, or better said not blocked, the occurrences of several cases of parallel importation, also legitimated or anyway not opposed by sentences of the European Court of Justice (v. sentences C-662/15 e C-642/16), although secondarily to the taking place of some conditions.

The topic is complicated by the convergence of different aspects: regulatory fields (as the rights conferred by the trade mark), application contexts (as the smooth functioning of the internal market), and legislators scopes (as the guarantee of a high level of safety and health). The final result can lead to apparently paradoxical or worrisome situations, if judged by the community or manufacturer viewpoint, although both one and the other should feel comforted by the limiting requirements to the parallel imports activity, that in failure to comply would prevent its existence.

The new Regulation 2017/745 (MDR), contrary to the old MDD, addresses in more details situations that can involve the parallel imports of medical devices, by introducing Art.16 and particularly its first paragraph. A parallel import can fall at least in letter a) of the first paragraph due to the making available on the market of the device under the third party name, registered trade name or registered trade mark. Thus, unless there is an agreement with the manufacturer and where the third party does qualify as distributor or importer, manufacturers obligations will apply to the third party.