WRITTEN QUESTION E-0775/02

by Charles Tannock (PPE-DE) to the Commission

(18 March 2002)

Subject: The cost of obtaining a CE marking, and whether or not this constitutes a trade barrier

Is the Commission aware that Tooray Inc of Japan withdrew in January 2000 its A78 moulded eye contact lens from the EU market as a result, in part, of the expense involved in obtaining a CE marking? The British Company, Nissel Ltd, which used to import the Tooray product into the UK went into liquidation and its product lines were taken over by Cantor and Nissel Ltd, which has produced a lathe cut lens to replace the Tooray product. Unfortunately, a number of my Constituents have not found the replacement entirely satisfactory. It is obviously undesirable if patients in the European Union are denied access to valuable new technologies from, say, America or Japan for this reason and vice versa. Is there any attempt to allow common recognition in this area? Is it also the case that the cost of CE marking requirements has the result of making small volume sales of quality products non-commercially viable and does this constitute a non-tarrif barrier and infringe WTO rules in any way?

Answer given by Mr Liikanen on behalf of the Commission

(22 April 2002)

The Commission is not aware that Tooray Inc withdrew a product from the Community market as a result of expenses involved in obtaining a CE marking.

Lenses are medical devices covered by Council Directive 93/42/EEC of 14 June 1993(1). One of the objectives of this Directive is to offer the widest choice of devices to users and patients, whilst ensuring the highest safety standards. This implies that for medical devices, except those in Class I, a Notified Body has to intervene in the conformity assessment procedure before such products can be placed on the market. Notified Bodies will charge a fee for their intervention, but manufacturers are allowed to work with any Notified Body of their choice, competent for the type of tasks for which the Body was notified. The Commission is not aware that fees charged are of a nature that they constitute a barrier to trade, nor that foreign manufacturers are discriminated with respect to manufacturers established in the Community.

The Community and its Member States are bound by the World Trade Organisation/Technical Barriers to Trade (WTO/TBT) Agreement that provides in Article 5.2.5:

Members shall ensure that any fees imposed for assessing the conformity of products originating in the territories of other Members are equitable in relation to any fees chargeable for assessing the conformity of like products of national origin or originating in any other country, taking into account communication, transportation and other costs arising from differences between location of facilities of the applicant and the conformity assessment body.

Third countries have their own regulations in terms of product certification before they can be put on their domestic market. The Community has entered into Mutual Recognition Agreements (MRAs) covering medical devices with the United States, Canada, Australia/New Zealand and Switzerland and there are provisions for CE marking to be affixed in those countries through locally designated Notified Bodies/Conformity Assessment Bodies. This process will contribute to lowering the cost of conformity assessment.

Medical devices are not included in the MRA with Japan but there is a commitment to begin negotiations within two years of 1 January 2002.

(1) OJ L 169, 12.7.1993.