Advocate General: no new CE conformity assessment required to sell parallel imported medical devices

Hoffman-La Roche (Roche), which manufactures and distributes CE-marked blood glucose testing strips in Europe, had challenged the ability of a wholesaler to sell testing strips, initially placed on the market in the UK, in Germany. The wholesaler, Servoprax, had copied Roche's German-language labelling on the products, other than the chemical values which were identical to those on the English language version.

Advocate general Eleanor Sharpston said that the relevant EU legislation was in place in order to appropriately balance free trade in in vitro diagnostic medical devices with high levels of health protection and performance. It would be inconsistent with the purposes of the legislation to require companies to carry out conformity assessments in the official language of every EU member state, not to mention "virtually impossible to implement in practice", she said.

"The opinion confirms that, where a device had undergone conformity assessment in accordance with EU legislation, it can be marketed throughout the EU without a new or supplementary conformity assessment," said life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com.

"It also seems from the advocate general's opinion that it is immaterial whether the leaflet and the packaging which the parallel distributor uses for the device do or do not correspond word-for-word to the leaflet and packaging provided by the manufacturer. However, this may be a question of degree: in this case the instructions for use were arguably not materially different," she said.

The case will now proceed to the Court of Justice of the European Union (CJEU) for judgment. Decisions of its advocate generals are not binding on the CJEU, but are followed in the majority of cases.

The EU's 1998 directive on in vitro medical devices harmonises the national rules of individual member states on device safety, health protection and performance, characteristics and authorisation procedures. Its requirements apply equally to the manufacturers of relevant products and those that assemble, package, process, fully refurbish or label such products for marketing them under their own names.

Roche manufactures two types of blood sugar measurement strips which enable diabetics to self-test their blood sugar levels under the names 'Accu-Chek Aviva' and 'Accu-Chek Compact'. Before releasing these products to the market, they were fully tested for compliance with EU regulations and awarded a 'CE mark' by a UK testing body. The products were then distributed in Germany by Roche's German distributor, after it added a label and instructions for use in German.

The German distributor challenged Servoprax's ability to distribute in Germany the version of the products manufactured for the UK market in the German courts. It alleged that Servoprax was in breach of the directive by distributing the UK products in Germany without carrying out a new or supplementary conformity assessment. However, the advocate general said that this was not required where the device had already been tested in another member state, "even where that member state uses a different official language".

"Once a device has undergone conformity assessment and bears the CE marking, member states may not create any obstacle to placing it on the market or putting it into service in their territory, subject only to the safeguard clause ... and the vigilance procedure [in the directive]," she said.

"The directive … strikes a careful balance between the free movement objective and the health protection objective … A manufacturer marketing a self-testing device is required to provide with it a translation of the label and instructions for use into the official language(s) of the member state(s) in which the device in question reaches its final user. Again, that does not involve a new or supplementary conformity assessment procedure," she said.

In addition, Servoprax's role was not that of a "manufacturer", bringing it within the requirements of the directive, the advocate general said. The directive was very clear that only the act of "placing a product on the market under one's own name" identified a manufacturer. Servoprax clearly identified itself as only the "importer and distributor" of the devices, she said.

"In my view it is immaterial whether the instructions for use which the distributor attaches to the devices marketed in the member state of distribution do or do not correspond word-for-word to the instructions for use which the manufacturer provides with those devices in that member state," she said. "That has no bearing on whether the distributor places the device on the market in his own name. It is therefore irrelevant for the purposes of ascertaining whether he is required to subject the device to a new conformity assessment."

"Furthermore, the conclusion that I have reached does not compromise the directive's objective of ensuring a high level of health protection," she said.