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UK Introduces Bill to Guide Future IVD Regulation

NEW YORK – The UK government this week introduced a new bill to govern the future regulation of medical devices and in vitro diagnostics.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU and had its first reading in the House of Commons on Thursday.

The UK joined the EU in 1973 and left last month. As an EU member state, regulation of medical devices and IVDs was considered an EU competence. The UK will continue to follow EU law during its transition period, which ends Dec. 31, 2020, but afterward it will need a new regulatory framework for assessing devices.

The newly introduced bill gives the government the power to set new regulations related to medical devices and IVDs. It also gives the government the power to issue compliance notices and the means to enforce its decisions. The government has published a copy of the bill, as well as an explanatory note describing its application in detail.

It is unclear what the future UK regulation will be. The UK's Medicines and Healthcare Products Regulatory Agency is responsible for overseeing the compliance of devices going forward. MHRA representatives have said previously that they would like to see UK regulations mirror European regulations on medical devices and IVDs following Brexit.