According to Directive 93/42/EEC of 14 June 1993 concerning medical devices (exclusive of active implantable devices, medicinal and cosmetic products, human blood and transplants of human and animal origins), "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 (...) which indicates that they have been subject of an assessment of their conformity in accordance with the provisions of the Directive". The Directive has not yet been implemented into Belgian law, although, according to the Directive, the Member States were supposed to adopt and publish the laws and regulations necessary to comply with the Directive not later than 1 July 1994 and to apply the same with effect from 1 January 1995.

Based on the above Directive, it may be concluded that any product bearing the CE marking may be freely imported into Belgium.

According to the Ministry of Public Health, however, the above Directive is said not to apply to the distribution of medical devices, which remains within the scope of domestic laws and, in particular, the Royal Decree of 6 June 1960 (as modified).

This R.D. sets forth the conditions under which a pharmaceutical company may be authorised to market (including import and wholesale distribution) medicinal products (as defined in the Law of 25 March 1964) as well as other specific products deemed as medicinal products.

These products are listed in the R.D. They include, among other things, any material of substitution or internal prosthesis, defined as any product or apparatus, regardless of its nature and exclusive from substances of human origin, meant to be introduced, for a long period of time or indefinitely, in the body.

Among the conditions to be met in order to be granted the authorisation to import and distribute wholesale, the applicant must file with the Ministry an application describing the categories of medicinal products for which the authorisation is requested.

Based on the opinion of the administration, it may be concluded that, should the categories of medicinal products described in the authorisation granted to a given pharmaceutical company not cover certain products already bearing CE marking that this company intends to import and distribute in Belgium, this company must apply for and be granted an additional authorisation covering the above CE marked products prior to importing and distributing them in the country.

The content of this article is intended to provide general information on the subject matter. It is therefore not a substitute for specialist advice.

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