UNTIL RECENTLY laboratory diagnostics have not been subject to regulation in Europe although for many years they have been falling into the remit of the United States Food and Drugs Administration. This situation has now changed with the introduction of a third medical device directive, the In Vitro Diagnostic Medical Device Directive (98/79/EC), which came into force on December 7. In the UK, this directive has been transposed under the Consumer Protection Act (specifically in the Medical Device Regulations 2002, SI no.618) with the Medicines and Healthcare products Regulatory Agency (MHRA) responsible for ensuring compliance. The UK was among the first states to transpose the directive into national law and was only one of three member states to do so within the required timetable.