The Future Of Medical Device Regulations

MedTech Innovation News

In the first of a series of articles for MedTech Innovation News, Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications and chair of the Urology Trade Association, keeps readers abreast of the major changes to MedTech investment, innovation and medical devices regulation that are on their way.

New Medical Device Regulations

The Medicines and Medical Devices Act and the Health and Care Bill are implemented; the new MedTech Directorate finds its feet, the Medicines and Healthcare products Regulatory Agency pivots to help innovators develop new products for approval rather than just to assess them; and a host of other government departments commit to driving forward innovation and exporting success

Two pandemic years have shone a bright light on the critical role of medical technology in delivering effective functioning in the healthcare system. Medical apps and other digital health technologies along with more traditional devices such as diagnostic tests, ventilators and catheters all played a vital role. Medical device regulation is at it’s most significant point, now more than ever.

Medical equipment on white background.

MedTech Regulation

Under quite unique circumstances, the UK government has made a finely balanced exit from the European Union. They have also minimised the impact on, and disruption within, the healthcare system, whilst ensuring the continuity of supply of vital medical equipment and devices. This then enables the NHS to maintain delivery of safe, high-quality patient care during an unprecedented global pandemic. The medtech sector has been crucial in that success. The extraordinary drive between suppliers, clinicians and operational teams to collaborate, enabled the UK to react quickly to these significant challenges and to innovate and produce at pace.

There have also been moments where the pandemic exposed vulnerabilities within existing processes and global supply chains. The supply of ventilators, facemasks and other PPE was initially, lamentably inadequate; and there were challenges with clinical consumables, capital and diagnostic equipment and digital health products – all of which at some point were difficult for the government and NHS to source.

The MedTech Investment Gold Mine

Even before the pandemic, government had identified medical technology as a sector that could not only reduce demands on the NHS, but also prove a real boost to the United Kingdom economy. The challenges thrown up over the past two years have accelerated the government’s thinking on medical devices, innovation, and procurement. The sector is identified as a unicorn for investment, encouragement and promotion.

The Queen’s Speech in 2021 set the path for the government to champion the life sciences sector, put in centre stage within its ‘build back better’ agenda. This was shortly followed by the re-emergence of the Independent Medicines and Medical Devices Safety Review, also known as the Cumberlege Review. The Review shone a light on the importance of appointing a patient safety commissioner and improving patient health by enabling the earliest access to, and high-quality supply of, safe, effective and innovative medical products.

MHRA Legislation

In recent months, the Medicines and Healthcare products Regulatory Agency (MHRA) concluded an extensive consultation on the future regulation of medical devices in the United Kingdom. MHRA seeks to develop a regime which improves patient safety, promote transparency and deliver alignment with international best practice. Whilst, most importantly achieving more flexible, responsive and proportionate medical device regulations. The executive agency will shortly be seeking secondary legislation that includes the new medical device regulations, and has now launched a series of roundtables targeted towards industry and other stakeholders to discuss the guidance that will accompany the incoming secondary legislation.


Woman holding digital thermometer.