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Health: Medicines

Volume 717: debated on Monday 8 February 2010


Asked by

To ask Her Majesty's Government what procedures are used to assess the safety of medical devices. [HL1588]

In order to place a medical device on the European Union market a manufacturer must meet the relevant safety, quality and performance requirements laid down in the European Community medical devices directives. These have been transposed into United Kingdom law by the Medical Devices Regulations 2002. All but the very lowest risk classified devices require their conformity to be assessed by third party certification organisations (called notified bodies) designated by member states as being competent to undertake this function.