EU: Free movement of medical devices bearing CE marking


The CJEU recently interpreted Article 4 of Directive 93/42/CEE on medical devices in response to a preliminary reference laid before it.

A Swedish company manufacturing an alloy destined for use in dental amalgams containing mercury was refused an exemption by the Kemikalieinspektionen (Chemical Products Inspectorate) due to the prohibition under Swedish law against exporting mercury for professional purposes both within the EU and beyond.

However the products in question were CE marked, and are therefore presumed to fulfil essential safety requirements and thus be satisfactory for free circulation within the EU.

The company referred the case to the Swedish district court, which decided partially in its favour, considering that the export prohibition as regards the EU and the EEA was contrary to Directive 93/42/EEC (Article 4) or Article 29 of the EC Treaty (prohibition of quantitative restrictions to exports). On the other hand, the Court considered that prohibition of export to third countries was not contrary to Community law.

On the preliminary issue, the CJEU considered on the contrary that Article 4 of Directive 93/42/EEC should “be interpreted as being opposed to the adoption by the Member States of measures likely to constitute an obstacle to the free circulation of medical devices bearing [CE] marking”; and therefore that national regulations could not prescribe for the prohibition of the export of medical devices bearing CE marking for reasons based on the protection of the environment and health.

In summary:

  • Compliance with the essential requirements set out in Directive 93/42/EEC is presumed by affixing the CE marking to medical devices. This guarantees free circulation within the EU.

  • No restriction may be imposed on such free circulation (other than special measures prescribed by the Directive – notably Article 8: Safeguard Clause; and Article 14(3): special health monitoring measures, implemented by a Member State which has informed the Commission where a medical device is likely to create a health and/or safety risk).

  • This prohibition is valid throughout the EU (and the EEA) and also outside the EEA, for both imports within the EEA and exports from the EEA.

  • The Court has made no pronouncement on the application of Articles 29 (prohibition of quantitative restrictions to exports) and 30 (restrictions on free circulation justified by public health reasons) of the EC Treaty. It seems that CE marking operates against Art. 30.