I would like to see harmonisation between European and UK regulations, or potential harmonisation with other global regulations, for example, with America and the FDA
Hugh Harvey
For healthcare professionals in the NHS, that will mean taking a longer term look at what they are buying in terms of hardware devices and software and speaking to manufacturers about their regulatory strategy going forward, and whether they plan to maintain a presence in the UK market. “At the moment we are in a transition zone where UK will accept Europe’s CE mark for a period of time but at some point, that will disappear,” he added. He believes that if there is to be closer alignments, the move will have to come from the UK as Europe has already introduced new MDR. “It is up to the UK to decide what they will do but I would like to see harmonisation between European and UK regulations, or potential harmonisation with other global regulations, for example, with America and the FDA.”
He suggests mutual recognition between the UK and America may be an interesting step, but emphasises that the UK must have some alignment strategy as it is “too small a market to set its own standards.” But there could still be an impact. “In a worst-case scenario, some medical devices may come off market and UK hospitals may need to change brands,” said Dr Harvey. “There are wide-ranging implications as all health areas will be affected; literally any product that is used in a hospital is going to be a medical device and could be anything from software to hardware, or rubber gloves to CT scanners.”
While there are government-level discussions taking place on these regulations, he warns it is going to be a long and slow process.
*The British Institute of Radiology congress takes place in a virtual format on November 4 and 5 (www.bir.org.uk). “Update on post-Brexit regulation for healthcare specialists” (Hugh Harvey) is at 10.30am on November 4.
Profile:
Dr Hugh Harvey is managing director of Hardian Health and an experienced clinician and health technology advisor, with a focus on leveraging big data and artificial intelligence. He is a board-certified consultant radiologist and academic, trained in the NHS and the Institute of Cancer Research. He was a co-opted member of the Royal College of Radiologists informatics committee and sat on their AI policy reference group.
Source: Healthcare in Europe
