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UK MHRA Weighs Additional Regulatory Requirements for Certain Classes of High-Risk IVDs


NEW YORK — The UK Medicines and Healthcare Products Regulatory Agency (MHRA) this month announced a four-week consultation with stakeholders over plans for additional regulatory requirements for higher-risk in vitro diagnostics. MHRA is the agency responsible for mapping out the future IVD regulatory framework for the UK, which is still emerging four years after the country officially left the EU.

The agency also recently published a statement of policy intent regarding pathways for tests cleared in the US, Canada, EU, and Australia to be more quickly placed on the UK market, though the new consultation is not directly related to that discussion.

As noted in a statement describing the consultation, IVDs in England, Scotland, and Wales, collectively referred to as Great Britain, are currently regulated under the country's Medical Device Regulations from 2002, as well as the Medicines and Medical Devices Act of 2021. Northern Ireland has remained within the European market, and tests there are regulated under the European In Vitro Diagnostic Regulation, which began to apply two years ago.

Placing an IVD on the market in Great Britain requires a manufacturer to obtain a UK Conformity Assessed or UKCA mark from an organization designated by MHRA to assess the compliance of the test with relevant regulations, called an approved body. The current common technical specifications for IVDs are covered under the regulation from 2002, and MHRA is now seeking to bring them current as it inches towards the enactment of a new Medical Device Regulation planned for next year.

Previously, the 2002 regulation covered a set, predetermined list of tests that were required to meet certain benchmarks. MHRA is now moving toward a risk-based classification system, where Class D high-risk IVDs would require more scrutiny. As MHRA outlined, this is being done partly to align the future regulation on medical devices with the EU's IVDR, as well as an accompanying document published by the commission in 2022 covering specifications for Class D IVDs.

MHRA in its statement on the consultation also said it plans to include common specification requirements for post-market performance follow-up plans, which will be used to monitor IVDs throughout their lifecycle, providing feedback on performance over time. According to MHRA, manufacturers that wanted to place a test on the market in Great Britain would also need to include information on such a plan while being assessed by an approved body.

Thirdly, MHRA in its future regulation would like to update the way tests for SARS-CoV-2 are assessed, having them meet common specification requirements rather than the requirements outlined for coronavirus test device approvals that are covered in the Medical Device Regulation from 2002. This would mean that approved bodies would assess a SARS-CoV-2 test just as they would a test for any other infectious disease. This would be done to avoid duplication of requirements for such tests, MHRA said.

The agency is now engaging with stakeholders over the next month to get their feedback on these proposed changes, with an eye to publishing a draft statutory instrument later this year that will guide the Medical Device Regulation foreseen for 2025. MHRA declined to comment on the consultation, citing Prime Minister Rishi Sunak's recent call for a July 4 parliamentary election.

In a statement, Laura Squire, medtech regulatory reform lead and chief healthcare quality and access officer for MHRA, said the agency is looking forward to feedback it receives from stakeholders, as it looks to "strengthen safety requirements around certain classes of crucial diagnostic devices."

The consultation is open to any member of the public, including manufacturers but also healthcare professionals, researchers, and patients. Stephen Lee, director of diagnostics and digital regulation at the Association for British Healthtech Industries (ABHI), said when asked about the consultation, as well as the statement of policy intent on international regulation, that ABHI is "actively engaging with our members and other stakeholders to develop our thoughts on the MHRA proposals."

Stuart Angell, the regulatory affairs program manager at the British IVD Association, as well as founder and managing director of the company IVDeology, said that he is "positive on this consultation" on IVDs, noting that it asks a few questions related to aligning UK common specifications to those in the EU IVDR.

"To me, this makes good practical sense as any UK-specific nuances would result in additional regulatory burden that would be a detriment to the UK," said Angell. He added that covering SARS-CoV-2 tests under a common specification, rather than one specifically for coronavirus tests, also is logical.

"This again makes good pragmatic sense as we come out of the COVID-19 pandemic," he said. "There is little value in having a separate process for COVID-19 tests."

In general, UK IVD manufacturers seem keen to support a new post-Brexit regulatory framework that doesn't place an additional burden on test makers in placing new IVDs on the market in Great Britain. Angell said that the final details on what that framework will look like are in flux.

"We need to wait until the statutory instrument is released in draft, which will provide greater and specific clarity on the process of international recognition," said Angell. He added that IVD makers still don't know what the domestic route for obtaining a UKCA mark for a test will be, but there is some hope that it will be a leaner process than what has unfolded with the IVDR, where various issues, such as a lack of designated notified bodies to evaluate submissions, have forced decision-makers to expand the grace periods for legacy devices.

"It may be that the UKCA process is commensurate with the market size and may remove the barriers previously seen in the implementation of EU IVDR, which would make UKCA more attractive," said Angell.

He noted that if MHRA's plan for allowing international recognition of tests cleared under the IVDR is enacted, for example, some companies might just place their tests on the market via the international recognition path, rather than seeking a UKCA through a domestic approved body.