Medical Devices

House of Lords written question – answered on 15th July 2008.

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Photo of Baroness Finlay of Llandaff Baroness Finlay of Llandaff Crossbench

asked Her Majesty's Government:

What plans they have to draw attention to differing interpretations by member states of the definition of a medical device as opposed to a medicinal product in the United Kingdom's response to the European Commission's current consultation on the recasting of the medical devices directives.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

None. The European Commission's consultation document on which interested parties are asked to comment, does not contain any proposals regarding the borderline between medical devices and medicines. The borderline is determined by the definitions of medical devices and medicinal products in their respective directives. This was only recently clarified in an amendment to the Medicinal Products Directive which came into force in 2005 and a more recent review of the Medical Devices Directive completed in September 2007 did not consider that any further adjustments were required. Any differences in interpretation can be raised by national regulatory authorities at a European level and reflected in guidance issued by the appropriate working groups to enable consistent application between member states.

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