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The Good and Bad of Draft UK IVD Regulatory Guidance, According to Experts

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NEW YORK – The UK may no longer be an EU member, but it is still crafting a framework for regulating in vitro diagnostics in the years to come.

Last week the Medicines and Healthcare Products Regulatory Agency (MHRA) opened a consultation on new regulations that will govern medical devices and IVDs, inviting members of the public to comment on proposed regulations before the consultation ends on 25 November. According to industry insiders, the UK has the chance to set new policies that will both keep the domestic IVD market safe, while keeping the country internationally competitive.

The consultation documents contain 15 chapters, covering device classification; registration procedures; rules governing organizations charged with assessing the conformity of devices (so-called approved bodies); regulations covering IVDs and software used as a medical device; and post-market surveillance requirements, among other topics.

Undertaken in line with the Medicines and Medical Devices Act of 2021, which was passed to enable the creation of a new regulatory framework post-Brexit, the overarching objective of the envisioned regulation is to safeguard the safety and availability of medical devices, as well as "the likelihood of the UK being seen as a favourable place" in which to develop and manufacture devices and IVDs.

MHRA noted in the consultation documents that the implementation of a new regulatory regime in the UK, separate from the EU's In Vitro Diagnostic Regulation, could "add to the compliance burden on manufacturers," which in turn could "detract from the favorability of the UK as a medical device market." However, the agency said the changes had to be effected with an eye to international best practice, and to bring the UK into alignment with requirements in other jurisdictions, such as the EU or US.

Doris-Ann Williams, chief executive of the British In Vitro Diagnostics Association (BIVDA), a trade organization representing UK IVD makers, noted the need to find a balance between providing for the safety of IVDs in the country while not overburdening test makers that may still need to gain EU approval for their products, not to mention clearances in other markets.

"I'm hoping it will not be too dissimilar to the EU IVD Regulation currently in transition," said Williams of the UK's proposed regulations.

Indeed, the EU is also moving into a new regulatory framework. Whereas under the older In Vitro Diagnostic Directive of 1998, most IVDs in Europe were able to gain regulatory compliance through a self-certification process, the new IVDR  enacted in 2017 and set to come into force next May  has created a new process for assessment reliant on certified standards organizations, called notified bodies (NB), to evaluate submissions prior to clinical clearance.

The transition to the IVDR, however, has been clouded by a shortage of NBs. Currently there are six organizations that have been certified by the EU to conduct such assessments, and the waiting lists for submissions is long, all factors that have caused some parties to advocate a delay or phased implementation of the IVDR. On top of that, manufacturers also have to contend with a lack of regulatory clarity around Brexit though, on the face of it, the proposed UK regulations mirror the IVDR, with the creation of a new certification mark, the UKCA, as well as the reliance on standards organizations, called approved bodies in Britain, to evaluate new tests.

Companies that wish to sell IVDs in the UK may do so until July 2023, by which time they are expected to obtain a UKCA mark from a government-sanctioned approved body. The rules, it's worth noting, apply to the island of Britain and its nations of England, Scotland, and Wales. Northern Ireland will continue to operate within a hybrid regulatory regime, where both the European CE-IVD and British UKCA are recognized. A mutual recognition agreement covering both markings has not yet been reached between the UK government and EU authorities.

"The UK government has a worthy ambition to be world-leading for regulation of medical devices," said Williams. "The practicality for IVD companies is that this could become yet another system to comply with, further adding to the cost of doing business for companies, particularly the small and medium-sized enterprises and startups," she said.

Williams said that BIVDA will be working on its responses to the proposed regulations in the coming weeks. Given the freshness of the proposed regulations, which were published online on Sept. 16, she declined to further comment on their content.

Stephen Lee is the director of diagnostics regulation at the Association of British Healthtech Industries (ABHI), which supports the healthtech community in providing products and services. He previously was a senior regulatory policy manager for the IVDR at the MHRA, where he worked from 1996 to 2020, and was a member and former chair of the European Commission's IVD Working Group.

Lee said the new consultation was an opportunity for ABHI to influence British IVD policy. "The starting pistol has fired," said Lee of the consultation. "This is our opportunity to lead on a key issue that will influence our industry for years to come across the whole spectrum of products including devices, digital health, and diagnostics," he said.

Lee said that ABHI intends to focus its activities on the proposed UKCA marking and will coordinate survey responses related to "deep dive areas" such as regulatory transition, labeling, IVDs, digital health, sustainability, research, and global alignment.

"Responses to the consultation will help to determine the future of patient safety and public health in the UK," noted Lee. "The consultation is also an opportunity to shape whether the UK will be seen as a favorable place to research, develop, manufacture, and supply devices," he said.

In sum, ABHI intends to work with its members to "collate a comprehensive response" that is representative of industry and makes sure the new regulations are globally aligned, he said.

The MHRA itself sounded a positive note when it opened the consultation last week. June Raine, its chief executive, called it an "exciting step" toward creating a regulatory framework for medical devices in the UK." She called the consultation a "once in a lifetime chance" to shape UK regulations governing medical devices and IVDs and welcomed feedback from a wide range of respondents. The MHRA has also made a questionnaire on the regulations available online.

While the implementation of a new regulatory framework covering IVDs in the UK will add one more jurisdiction for test makers to sell into, the MHRA did say in its proposed regulations that it is contemplating adding routes to smooth the path to the clinical market. In one scenario, the MHRA could allow manufacturers with a certificate from the Medical Device Single Audit Program to apply for an abridged assessment with an approved body. The program allows for a single audit of a manufacturer's quality management system. Australia, Brazil, Canada, Japan and the US are already part of the program.

"Introducing alternative routes to market could have a number of benefits, for example in enhancing the supply of devices to the UK for medical devices regulation to become globally harmonized," the MHRA wrote.

Muddied waters

When the UK left the EU, Northern Ireland's border with Ireland was a key matter of negotiations, as lawmakers on both sides wanted to avoid a hard customs border on the island of Ireland between the UK and EU, of which Ireland is part. The resulting agreement, called the Northern Ireland Protocol, allowed for EU regulations on medical devices and IVDs to continue to apply in Northern Ireland. That means that the IVDR will apply in Northern Ireland as of May 2022, as will new UK regulations. What it also means is that goods arriving from Great Britain are checked at Northern Ireland ports, creating what some argue is a de facto customs border.

In its new consultation documents, the MHRA said that it welcomes views regarding alignment across all of the UK's nations, and that the government is seeking a new balance to the Northern Ireland Protocol. The MHRA also said it has proposed a dual regulatory regime in Northern Ireland, where goods that meet either UK or EU regulations could circulate in the region. The UK this past summer unilaterally set aside some grace periods for certain products arriving from Great Britain to Northern Ireland, prompting a reaction from the EU and ongoing deliberations.

This uncertainty could hurt Northern Ireland's IVD sector, noted Seamus Kearney, CEO of ARC Regulatory, a Belfast area company that advises firms on regulatory compliance.

"The ongoing stasis over the Protocol and Northern Ireland is an unwelcome state of affairs" for businesses in the region, he said, adding the MHRA consultation may "further muddy the waters" for medical device companies in the region, which actually stand to benefit from being able to develop and clear and sell tests for both the EU and UK markets within the same region.

"Rather than working to take advantage of the huge benefits that the protocol provides for Northern Ireland, businesses along with overseas investors are holding off, hoping for stability before making investment decisions," said Kearney. "That said, if the UK government gets their regulatory regime right, then the UK may become one of the first jurisdictions that manufacturers choose for product launch," Kearney added.

Kearney noted that the new regulatory regime in the UK will mean more regulation for IVD makers, not less, as there will be new considerations for products seeking a UKCA mark. He said that the UK government should try to minimize regulatory divergence for the EU and to "foster innovation that borrows from international best practice, and that develops a collaborative regulatory environment that expedites access to safe and effective medical technologies."

Should it succeed in developing new regulatory pathways, Kearney said that Northern Ireland could benefit from early global access to any new technologies UKCA-marked by approved bodies under the new regulations.