WRITTEN QUESTION E-0775/02 by Charles Tannock (PPE-DE) to the Commission. The cost of obtaining a CE marking, and whether or not this constitutes a trade barrier.
Date: 2002-03-18
Institutions: European Parliament, Provisional data
Subjects: EC conformity marking, Japan, World Trade Organisation, marketing restriction, medical device, mutual recognition principle, quasi-fiscal charge, safety standard

6.3.2003

EN

Official Journal of the European Union

C 52 E/19

(2003/C 52 E/020)

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
tasks for which the Body was notified.
for the type of
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.

their choice, competent

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.