Health: Medical Devices and Medicinal Products Directive

Lord Walton of Detchant
asked Her Majesty's Government:

Whether they have any plans to seek amendment of the Medical Devices and medicinal products directives, which control the classifications of products licensed for use across the European Union, with a view to clarifying the status of some borderline products; and [HL3170]

Whether they regard it as appropriate that copies of a proprietary laxative preparation, licensed in the United Kingdom and classified as a medicinal product under the medicinal devices and medicinal products directives, are being sold in some countries of the European Union as medical devices. [HL3171]

The Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham)
There are no current plans to amend either the medical devices or the medicinal products directives in order to clarify the status of some borderline products. The definition of a medicinal product in the Community code relating to medicinal products, the directive on medicinal products, was only recently clarified with regard to the borderline with medical devices and other legislation in an amendment to the medicinal products directive which came into force in 2005. The medical devices directive was only recently amended in September of 2007 when the legislators considered that there was no need to further clarify the borderline with medicinal products.

The Medicines and Healthcare products Regulatory Agency which is responsible for the regulation of medicinal products and medical devices in the UK, is aware of differences between the regulation of laxative preparations within Europe and has been actively seeking to have these discussed at a European level and included within relevant publications to enable a consistent interpretation between member states.