MHRA consultation: Considering the UK regulatory landscape


Professor James Moore, Department of Bioengineering, Imperial College London, provides an overview of the considerations the MHRA will have when developing the regulatory pathway for medical devices in the UK.

When Sir Andy Murray needed a hip prosthesis to maintain as much movement and stability as possible, he turned to a device developed in Birmingham. The Birmingham Hip Resurfacing System was developed in the UK with the knowledge that once certified it could be sold throughout the EU. Regulatory approval in the United States followed, gaining access to the two largest markets for health devices.

After Brexit, medical devices in the UK will now have their own regulatory path for approval by the Medicines and Health Products Regulatory Agency (MHRA). A new consultation appears to envision the creation of an alternative regulatory environment to both the EU and the US. Such a move will not only limit the sale of innovative devices in the UK market due to additional regulatory hurdles, but will also deter manufacturers from relocating to the UK.

The UK accounts for just 3% of global healthcare spending – too little to insist that these companies submit stacks of additional documents beyond what is required in larger markets. Other countries with similar sized markets recognize European or American approvals for this reason. Moreover, if the UK market is not a priority in terms of size, why is there a serious presence?

World-class universities and the UK’s knowledge base produce vast intellectual property to build a strong medical technology sector. But start-ups, including the spin-offs from our master’s program in medical device design and entrepreneurship at Imperial College, will simply move into larger, more convenient markets.

According to the MHRA’s own estimates, almost any proposed change in the consultation will reduce the availability of medical devices and make the UK less welcoming to the development of new devices. Some devices with years of safe use in the NHS could be taken off the market. The MHRA says these new measures will improve safety, but provides no supporting evidence. Critics of current device regulations sometimes point to the PIP breast implant scandal as support for tighter regulation. However, this scandal was rooted in fraud. The problem was not the regulation but its enforcement.

To attract more innovation and manufacturing of medical devices that can support the health of the country, the MHRA must first align with international approval processes. With this foundation in place, the MHRA certainly has the potential to draw on UK expertise and develop a buoyant medical device market.

A strategic change mentioned in the consultation would help both NHS patients and local industry. The MHRA is investigating “new pathways to market,” including a special pathway for rare disease treatment devices. They say: “These proposals have the potential to streamline access to our market, making the UK a more favorable market for manufacturers. “

The United States Food and Drug Administration (FDA) has such a mechanism to expedite approval – the Humanitarian Device Exemption (HED) – that it has no equivalent on this side. of the Atlantic. The HDE approval keeps safety at the forefront while imposing other conditions such as the obligation to collect additional safety and performance data and limiting the profits that can be realized. For some patients, the devices that go through this program are their only hope for a normal life.

Take scoliosis, an abnormal curvature of the spine that affects about 2% of adolescents and can be severely disabling. Traditional strategies such as external braces and exercise can help in mild cases, but many patients continue to deteriorate.

In 2019, medical device maker Zimmer received special clearance from the FDA to treat these patients with a device that attaches to the spine and gradually brings it back into alignment. But a review of the NHS evidence of the same technology concluded that there was not enough evidence to make the Zimmer device available to NHS patients. This captures the problem: such evidence will never exist unless there are mechanisms like HDE that allow device makers to put it together. It also highlights a central judgment for regulators: confidence in safety versus the needs of real patients today.

The UK has a once in a generation opportunity. The MHRA must create a regulatory system that draws on the best of its peers globally, prioritizing safety and regulatory alignment, while fostering technological advancements. If so, the nation will benefit as much as the patients. But if new barriers are erected, innovation will seek more welcoming homes, and NHS patients and clinicians will suffer the consequences.

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