Answer given by Mr Dalli on behalf of the Commission
Filling products are intended for a medical purpose, e.g. for reconstructive surgery, may fall within the scope of Directive 93/42/EEC(1). This directive requires that medical devices do not compromise the clinical condition or the safety of patients. Under this directive, filling products would be considered as long-term surgically invasive devices and, as a result, would be classified as class IIb or class III medical devices, i.e. the two highest risk classes of medical devices. A Notified Body, designated by a national authority, would be, therefore, involved in the conformity assessment procedure of these products before they can be placed on the market. With regards to incidents, a medical device vigilance system is in place to improve the protection of health and safety of patients. Directive 93/42/EEC establishes also specific procedures which the national authorities need to follow when they consider that an unsafe medical device must be withdrawn from the market.
In certain circumstances, filling products may fall under the definition of a medicinal product as laid down in Directive 2001/83/EC(2). In this context, the medicinal product has to be assessed for its quality, efficacy and safety before being placed on the market. Furthermore, marketing authorisation holders of medicinal products are obliged to regularly submit to competent authorities Periodic Safety Update Reports to inform on all adverse reactions related to a given product as part of the pharmacovigilance monitoring. At any moment, the competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation of a medicinal product if a scientific opinion concludes that the product is harmful under normal conditions of use.
In practice the Commission is aware that filling products, be they medical devices or pharmaceuticals, may be used, outside of their intended use, for aesthetic purposes. Although the Commission has no possibility to take any action in that respect, Member States authorities may take measures to discourage the off-label use of such substances for aesthetic purpose, for instance through information campaigns.
If filling products were intended exclusively for aesthetic purposes, they would fall outside the scope of the medical devices and pharmaceuticals legislations. These products, if sold or made available directly to consumers, would however still fall within the scope of the general products safety Directive 2001/95/EC(3) which requires producers to place only safe products on the market.
The Commission is considering a revision of the European legal framework for medical devices in order to improve and strengthen this framework and meet the growing expectations of European citizens. In that context, the Commission consulted stakeholders in 2008 on various issues identified(4). One of these issues is whether it would be appropriate to take any action vis-à-vis implantable products without any medical purpose, for instance filling products for aesthetic purpose only. On the basis of the outcome of this consultation, and other data collected, the Commission plans to present a legal proposal in 2011 and will propose, if necessary, measures to ensure the safety of such implanted products subject to EU competence.