Published 22 Nov 2021
The regulatory landscape for medical devices in the United Kingdom is changing. The long-standing CE mark – which shows a product has met certain safety and performance requirements in the European Union – is being replaced by a new British standard: the UKCA mark. While the In vitro Diagnostic Medical Device directive (IVDD) remains applicable until 2022, the MHRA is currently consulting on new regulations.
The new regulations are aimed at “improving the standards and scrutiny of medical devices that reach UK patients,” and at Genomics plc, we welcome that goal absolutely.
We are ISO 13485: 2016 certified. We comply with this standard for medical device quality management systems to ensure that our products are always of the highest quality, that we have appropriate checks and balances in place, and that our actions are reproducible. This makes it more straightforward for us to UKCA-mark a device.
Safety and accuracy are the centre of all that we do, whether the product is intended for research or for use as a medical device. All of our products are developed in compliance with the medical device software development standard IEC 62304: 2006 and the medical device risk management standard ISO 14971: 2019.
In keeping with this commitment, we have recently registered our first UKCA marked device with the MHRA. The product – SierraUK – is an integrated risk tool intended for use by clinical laboratories to estimate 10-year risk of cardiovascular disease for individuals aged 45 to 65 by combining genetic risk with traditional clinical risk factors.
We are committed to ensuring that all of the products we develop, whether for clinical use or for research, are developed to medical device standards and meet or exceed regulatory requirements. Patient or participant safety is always our priority.