Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Regulation of In Vitro Diagnostic Medical Devices in Great Britain" that outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices in Great Britain.
The purpose of this guidance is to provide information about requirements in Part IV of the UK Medical Devices Regulations 2002 (as amended) (UK MDR 2002) specifically relating to in vitro diagnostic devices placed on the market in Great Britain (England, Wales, and Scotland).
This guidance aims to provide manufacturers, importers, and distributors operating in the UK market with a comprehensive resource on IVD medical devices.
By following these guidelines, IVD devices will meet the necessary standards of safety, performance, and quality, which will protect public health and promote industry innovation.
There are various conformity assessment routes available for IVD devices, including self-certification, involvement of a notified body, and transition from the previous IVD Directive, according to MHRA guidance. Detailed information is provided on how to demonstrate compliance with the IVDR by presenting technical documentation, evaluating performance, and using quality management systems.
UKCA marks may be used on a voluntary basis by manufacturers until 30 June 2030, and CE-marked medical devices will continue to be accepted in Great Britain, depending on the type of device and its compliance with legislation; the latest deadline is 30 June 2030.
By adhering to this guidance, manufacturers can ensure compliance with the IVDR, thereby contributing to the safety, effectiveness, and quality of IVD devices available in the market.