Bodies set up to decide upon the regulation of medical devices did not have competence to decide whether an article was itself a medical device rather than a cosmetic. That issue is for the national courts. They could only decide upon the issues provided for by the Directive, and not whether the Directive applied.
Times 28-Jul-1999, Gazette 11-Aug-1999, [1999] EWCA Civ 1737
Council Directive 93/42/EEC on Medical Devices
England and Wales
Updated: 14 June 2021; Ref: scu.146652
