MHRA plans to align with EU common specifications for high-risk IVDs

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to update its Medical Devices Regulations 2002 for Great Britain to align with the EU Common Specifications for high-risk in vitro diagnostic (IVD) devices. The move is another step in the agency's series of measures to reduce administrative burdens by aligning itself with trusted international regulators.

Last year, MHRA proposed three major changes to update its regulation of high-risk IVDs and asked for public feedback. The agency noted that under the current system, IVDs are not allowed on the market without a UK Conformity Assessed (UKCA) marking except in certain circumstances. (RELATED: MHRA proposes requirements for high-risk IVDs, Regulatory Focus 22 May 2024)

The agency proposed using common specification requirements to evaluate certain Class D IVDs, so they are consistent with European regulations, particularly EU Commission Implementing Regulation 2022/1107. It also proposed using common specification requirements in a Post Market Performance Follow-up (PMPF) Plan.

Furthermore, it proposed ending the Coronavirus Test Device Approval (CTDA) process to prevent duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements and reduce burdens on test manufacturers.

MHRA said that respondents to the proposed changes overwhelmingly supported repealing the current CTDA process for COVID-19 tests and replacing it with the Common Specifications. The agency said that while it makes the updates, it will use an accelerated CTDA process to evaluate COVID-19 diagnostics that already have CE marking under the European IVD regulations (EU IVDR) and meet Common Specification requirements. It says it will also enhance requirements for performance standards for infectious disease IVDs such as those to diagnose Hepatitis B, C and D, HIV, Syphilis, and those to test blood grouping and tissue typing.

“These new specifications will be introduced in regulations expected to be published later this year as part of the Government’s broader program of medical devices regulatory reform, which supports the [National Health Service (NHS)] transformation,” said MHRA in a statement. “The changes reinforce the Government’s commitment to reduce regulatory burden and balance robust patient safety measures with support for innovation in the medical technology sector.”

This isn’t the first time MHRA has aligned its regulations to take advantage of global harmonization and international recognition. Last year, the agency proposed a medical device recognition path to allow products on the UK market faster if they are authorized in a comparable regulator country (CRCs), beginning with regulators in Australia, Canada, the EU, and US. (RELATED: MHRA proposes recognition path for devices cleared by trusted regulators, Regulatory Focus 21 May 2024)

Later in 2024, it asked stakeholders for input on a new international reliance scheme for products already approved in CRCs, new requirements for the UK Conformity Assessed (UKCA) marking, regulatory requirements for IVD devices, and removing the revocation date on certain assimilated European Union (EU) laws. (RELATED: MHRA wants feedback on updating IVD, medical device regulatory framework, Regulatory Focus 15 November 2024)

MHRA CEO Lawrence Tallon also recently spoke at the DIA Global Annual Meeting where he said the agency is taking a pragmatic approach to regulating products considering their limited resources. He added that they want to increase their international reliance and recognition of partnerships to reduce hurdles so that sponsors don't have to seek multiple overlapping approvals. (RELATED: MHRA leaders tout pragmatic approach to regulation post-Brexit, Regulatory Focus 17 June 2025)

MHRA plans to align with EU common specifications for high-risk IVDs

Related topics

Recommended content

Welcome to the new RAPS Digital Experience