The medical device industry tests plans for disagreements after Brexit


Industry experts warned that if the UK deviates from EU standards in order to seek regulatory dividends after Brexit, the UK’s hopes of becoming a new global medical device innovation center after Brexit will be stifled.

Before the formal government consultation process later this summer, departmental leaders from industry and academia stated that there is growing concern that the UK is setting the wrong direction for future regulation.

After Brexit, the UK decided not to implement New EU Medical Device Regulations (MDR)This puts a greater burden on the company to prove that the equipment is safe and benefits patients, because the failure of breast implants and surgical nets has triggered a series of scandals.

Instead, the UK is seeking to establish a customized regulatory system, according to Lord James Bethell, the Minister of Innovation for the Health Department, Said this month It aims to “seize the innovative opportunities we have left the EU.”

However, the early drafts of the new regulations seen by insiders disturb the industry. According to data from Imperial College London, the industry relies heavily on exports to the EU market, accounting for nearly 22% of global healthcare expenditures, and this proportion Only 3%. in England.

Kevin Kiely, chief executive of Medilink UK, a professional association that represents more than 1,300 small companies that manufacture medical devices, said that the UK system “absolutely” needs to emulate the EU system because British companies sell their products there.

“The early draft is not encouraging. The reality is that we have to sell products to Europe, so all companies must comply with the MDR anyway. The last thing they need is another audit trail, repeating what they have already done in Europe Things,” he said.

Senior scholars also warned that patients and industries are at risk of losing British innovations because investors will spend time and money registering equipment in the EU or the United States, which account for 43% of global health expenditures.

James Moore, professor of medical device design at Imperial College London, said that differences in the UK regulatory system may hinder investment and retention of successful products after they go public.

“The worrisome thing is that you will see companies established in the UK suffer-they will only evaporate and move to another country,” he said.

Derek Hill, a professor of biomedical engineering at University College London, said that although the UK’s unique system retains some potential for benefits, it may place further burdens on the company.

“It is difficult for the UK to become a truly independent regulator. If we want to be more friendly to innovation, the problem is that you are making UK-specific rules and tests. The company may ask,’Will we interrupt?’,” he said.

The British government has agreed to continue to recognize the EU’s standard “CE” mark before July 2023, while establishing a new regulatory system. Negotiations will begin this summer, and secondary legislation will clarify the new rules that are expected to be introduced in the spring of 2022.

The CEO of Yaqrit, Daniel Green, is a spin-off company of University College London. The company is obtaining certification for a revolutionary dialysis machine for patients with liver cirrhosis. He said that any customized new UK regulations must be applied to patients. Obvious benefits.

Daniel Green: “If any country tries to set additional barriers to approval, the industry will respond to these incentives.”

“If we have to obtain regulatory approvals to invest in the United States, the European Union, and the United Kingdom, each country’s return on capital will be different, and the best return will attract capital. If any country tries to put additional barriers to approval, the industry will respond to these Incentives respond,” he said..

Giovanna Forte, CEO of Forte Medical, who recently introduced urine testing equipment to the market, said that the long-term goal should be to create a global standard, coordinated and mutually recognized rules in various jurisdictions, rather than diverging.

“I don’t understand why the UK should have a different standard from the EU. There is a certain contradiction with this government, they say it will make everything easier, but these people don’t know how to run a business, they never know,” Ford said .

After several larger suppliers decided to withdraw from the market, British innovators in the industry were already in trouble due to the lack of professional assessments or “designated bodies.” There are only three approved institutions Medical devices used in the UK.

ABHI, the main UK medical technology industry association, stated that it is working with the UK regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) to establish a regulatory system that will make the UK an attractive place for product introduction.

Phil Brown, director of regulatory and compliance issues at ABHI, said that in an industry made up of 90% of small and medium-sized enterprises, “unconsidered disagreements” and regulatory duplication will “increase costs and reduce innovation” and are therefore extremely cost-sensitive.

Giovanna Forte: “I don’t understand why the UK should adopt a different standard from the EU”

However, he added that given the difficulties in implementing MDR in the EU, the “designated body” is trying to keep up with the pace of change, and the UK may design a more flexible and global-focused system.

A key requirement is to ensure that the test data collected for registration in the European Union and the United States should be compatible with obtaining registration in the United Kingdom.

MHRA, this is also Seeking to be a fast regulator The post-Brexit innovative drug company said in a statement that its goal is to create a “first-class” regulatory environment based on international best practices.

Although most people in the industry are worried that there will be differences, in some respects they still hope that the new British system can provide a faster way to market certain products while sticking to the core of the EU data system.

The UK can move beyond the increasingly bureaucratic EU system, which includes better oversight of medical device software, easier access to low-risk projects, and faster interaction with early-stage companies.

Neelam Patel, chief executive of MedCity, a London-based life sciences cluster organization, said that the UK can find the best points of regulation while using the NHS as a unique patient test bed for new products.

“MHRA has a great opportunity to take current things and develop them into long-term needs, not only for patients, but also for the company and the market as a whole,” she said.



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