(Reference for a preliminary ruling Directive 93/42/EEC Medical devices Prohibition on the exportation of dental amalgam containing mercury and bearing the 'CE' conformity marking Protection of health and the environment)
- This reference for a preliminary ruling concerns the interpretation of certain provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), in the version applicable at the time material to the main proceedings ('Directive 93/42') and, in the alternative, the interpretation of Articles 29 EC and 30 EC.
- The reference has been made in proceedings between Kemikalieinspektionen (Swedish Chemicals Inspectorate) and Nordiska Dental AB ('Nordiska Dental') regarding the refusal of the application submitted by Nordiska Dental for a waiver of the prohibition on the exportation of mercury, or of chemical compounds containing mercury, in the course of marketing amalgam for dental use during the period from 1 January 2007 to 31 December 2009.
Legal context
Community law
- The third and fifth recitals in the preamble to Directive 93/42, which are relevant to the present case, state that:
'...the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonised in order to guarantee the free movement of such devices within the internal market;
...
... medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; ... therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive'.
- The medical devices which come within the scope of Directive 93/42 pursuant to Article 1(1) thereof are defined in Article 1(2)(a) as follows:
''medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means'.
- Article 3 of Directive 93/42 provides, in the following terms, that medical devices are to be subject to essential requirements:
'The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.'
- Article 4(1) of Directive 93/42 imposes the following obligation on Member States:
'Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.'
- Article 8 of Directive 93/42, entitled 'Safeguard clause', permits the Member States to adopt the following measures:
'1. Where a Member State ascertains that the devices referred to in Article 4(1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied;
(c) shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6,
the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community.
3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.'
- Article 14b of Directive 92/43, entitled 'Particular health monitoring measures', is worded as follows:
'Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article [30] of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).'
- Article 17(1) of Directive 93/42 provides:
'Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.'
- In Annex I to Directive 93/42, to which Article 3 of that directive refers, point 1 of the section relating to 'General requirements' (Section I) specifies that:
'The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.'
National law
- Paragraphs 8 and 11 of Swedish Ordinance (1998:944), which concern, inter alia, the prohibition of the importation and exportation of chemical products in certain cases in connection with trading (förordningen (1998:944) om förbud m.m. i vissa fall i samband med hantering, införsel och utförsel av kemiska produkter; 'Ordinance (1998:944)'), lay down the following rules:
'8 The commercial exportation from Sweden of mercury, or chemical compounds containing mercury, is prohibited.
...
11 If the specific circumstances so warrant, the Kemikalieinspektionen may adopt provisions derogating from the prohibitions laid down [inter alia in Article 8].
If the specific circumstances so warrant, the Kemikalieinspektionen may, in a particular case, grant a waiver from the prohibitions laid down [inter alia in Article 8].'
The dispute in the main proceedings and the questions referred for a preliminary ruling
- Nordiska Dental manufactures alloy for dental amalgams and, for that purpose, imports prepacked mercury. The European Union accounts for 72.5% of its sales. The products sold by Nordiska Dental bear the CE marking provided for in Article 17(1) of Directive 93/42.
- With the intention of exporting dental amalgams, Nordiska Dental applied to the Kemikalieinspektionen in July 2005 for a waiver to cover the period from 1 January 2007 to 31 December 2009 from the prohibition, laid down in Article 8 of Ordinance (1998:944), on the commercial exportation of mercury or of chemical compounds containing mercury. Nordiska Dental had already been granted such a waiver twice, in respect of earlier periods.
- By decision of 14 December 2005, the Kemikalieinspektionen refused the application. Nordiska Dental contested that decision before the Stockholms tingsrätt (Stockholm District Court), which partly upheld its action, holding by judgment of 20 June 2006 that a prohibition such as that laid down in Swedish law on the exportation of dental amalgams containing mercury to the other Member States of the European Union or to States belonging to the European Economic Area is contrary to Article 4(1) of Directive 93/42 or to Article 29 EC. However, that court held that such a prohibition is not contrary to Community law to the extent that it concerns exports to non-Member States.
- The Kemikalieinspektionen appealed against that judgment to the referring court.
- On the view that the dispute before it raises questions as to the conformity of the Swedish legislation at issue in the main proceedings with Directive 93/42 and, as the case may be, with Articles 29 EC and 30 EC, the Svea Hovrätt decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
'1a. Are the provisions of Directive [93/42] to be interpreted as precluding the application of a national prohibition on commercial exports from the country in question of dental amalgam containing mercury which is based on considerations of environmental and health protection?
1b. Does the fact that the product concerned bears the CE marking have any bearing on that interpretation?
2. If the answer to the first question is negative, are Paragraphs 8 and 11 of [Ordinance (1998:944)], which are based on the considerations mentioned above, compatible with Articles 29 EC and 30 EC where those provisions are applied to dental amalgam which contains mercury and which bears the CE marking?'
The questions referred
The first question
- The first point to be noted is that the order for reference makes it clear that the export prohibition at issue in the main proceedings concerns dental amalgams bearing the 'CE' marking referred to in Article 17 of Directive 93/42.
- By its first question, the referring court accordingly asks, essentially, whether Article 4(1) of Directive 93/42 must be interpreted as precluding legislation of a Member State, such as the legislation at issue in the main proceedings, under which the commercial exportation of dental amalgams containing mercury and bearing the 'CE' marking provided for in Article 17 of that directive is prohibited on grounds relating to protection of the environment and of health.
- As is apparent, in particular, from the third recital in the preamble to Directive 93/42, the aim of that directive is the harmonisation of provisions for safety and health protection with regard to the use of medical devices, in order to guarantee the free movement of such devices within the internal market. In that connection, it should be pointed out that the reference to free movement is made solely in relation to movement between the Member States.
- The Court has already ruled that, in so far as Directive 93/42 constitutes a harmonisation measure adopted pursuant to Article 100a of the EEC Treaty (which became Article 100a of the EC Treaty; now, after amendment, Article 95 EC), it is intended to promote the free movement of medical devices which have been certified as being in compliance with that directive, precisely by replacing the various measures which have been taken in this field in the Member States, and which may amount to an obstacle to that free movement (Case C-6/05 Medipac-Kazantzidis [2007] ECR I-4557, paragraph 51).
- In view of that purpose, Article 4(1) of Directive 93/42, which requires Member States not to create any obstacle to the placing on the market or the putting into service within their territory of medical devices bearing the 'CE' marking provided for in Article 17 thereof, must be interpreted as precluding the adoption by Member States of measures liable to constitute an obstacle to the free movement of medical devices bearing that marking, such as, for example, an export prohibition.
- In that regard, it should be pointed out that, in accordance with Article 17(1) of Directive 93/42, medical devices bearing the 'CE' marking are considered to meet the essential requirements referred to in Article 3 of that directive.
- Nevertheless, it should be borne in mind that that presumption of compliance can be rebutted in certain circumstances.
- In particular, Article 8(1) of Directive 93/42 places Member States which have found there to be risks, linked to medical devices which have been certified as being in compliance with that directive, to the health and/or safety of patients or users or, where applicable, other persons, under a duty to take all appropriate interim measures to withdraw those medical devices from the market, or to prohibit or restrict their being placed on the market or put into service. In those circumstances, the Member State concerned is required under that provision to notify the Commission immediately of the measures taken, indicating in particular the reasons for those measures. Under Article 8(2) of Directive 93/42, the Commission must in turn examine whether those interim measures are justified and, where that is found to be indeed the case, it must immediately inform the Member State which initiated the measures, as well as the other Member States, accordingly (see Medipac-Kazantzidis, paragraph 46).
- By virtue of Article 14b of Directive 93/42, concerning particular health monitoring measures, where a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 30 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may also take any necessary and justified transitional measures. The Member State concerned is then to inform the Commission and all the other Member States accordingly, giving the reasons for its decision.
- In the dispute before the referring court, the export prohibition laid down by the legislation at issue in the main proceedings applies to dental amalgams, which constitute medical devices within the meaning of the third indent of Article 1(2)(a) of Directive 93/42.
- With regard to the argument that such legislation is outside the scope of Article 4(1) of Directive 93/42 and, more generally, outside the scope of that directive as a whole, on the ground that the objective pursued by that legislation is protection of the environment, it should be noted that the very wording of the first question makes it clear that the export prohibition at issue in the main proceedings is based on considerations relating to environmental protection and health protection.
- Furthermore, it is apparent from the observations submitted to the Court by the Swedish Government that the environmental protection objective on which that government relied also embraces the objective of protecting health and ensuring the observance of public health requirements, as referred to, inter alia, in Article 14b of Directive 93/42.
- The aim of Directive 93/42, on the other hand, is as is apparent notably from the recitals in the preamble thereto not only the protection of health stricto sensu but also the safety of persons. Moreover, that directive does not concern only patients and users of medical devices but, more generally, 'third parties' or 'other persons'.
- In those circumstances, it cannot be accepted that a measure prohibiting the exportation of dental amalgams containing mercury, such as that laid down by the legislation at issue in the main proceedings, can be regarded as outside the scope of Directive 93/42 merely by virtue of the fact that, although one of the aims of that legislation is health protection, it is also based on considerations relating to protection of the environment.
- In any event, contrary to the assertions of the Swedish Government in particular, it cannot be inferred from that interpretation that any measure adopted by a Member State on environmental matters a measure on the treatment of waste, for example will fall within the scope of Directive 93/42 if it concerns medical devices.
- Moreover, it does not emerge from the case file that the export prohibition at issue in the main proceedings was introduced within the framework of the special safeguard provisions provided for in Directive 93/42, which were referred to in paragraphs 24 and 25 of the present judgment.
- Having regard to the foregoing considerations, the answer to the first question is that Article 4(1) of Directive 93/42 must be interpreted as precluding legislation of a Member State, such as the legislation at issue in the main proceedings, under which the commercial exportation of dental amalgams containing mercury and bearing the 'CE' marking provided for in Article 17 of that directive is prohibited on grounds relating to protection of the environment and of health.
The second question
- In the light of the answer given to the first question, it is not necessary to reply to the second question raised by the referring court.
Costs
- Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (Second Chamber) hereby rules:
Article 4(1) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, must be interpreted as precluding legislation of a Member State, such as the legislation at issue in the main proceedings, under which the commercial exportation of dental amalgams containing mercury and bearing the 'CE' marking provided for in Article 17 of that directive is prohibited on grounds relating to protection of the environment and of health.
[Signatures]
* Language of the case: Swedish.
