The UK medical devices regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), has announced the changes to UK medical device regulatory will be postponed from July 1, 2023 to July 1, 2024.
The UK MHRA is currently in the process of significantly revising UK medical device legislation. As one of the first reforms of industry level legislation post-Brexit, the United Kingdom is seeking to reduce the regulatory burden on business by partnering with international requirements and European Union.
The legislation, which covers both medical devices and in vitro diagnostic medical devices, mainly reflects the previous medical devices directive of the European Union rather than the new European Union Medical Devices Regulation and In Vitro Diagnostic Device Regulation.
The UK Medical Devices Regulation, which applies in Great Britain will bring UK legislation into close partnership with the European Union MDR, as well as with international standards. The new UK MDR had been expected to come into force on July 1, 2023. However, the UK MHRA is also still drafting the new legislation based on the response of the UK government to its consultation.
The delay will also give the industry more time to transition existing products to the new regime of UK and to become approved to ease current capacity constraints.