MHRA proposes requirements for high-risk IVDs

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is proposing significant changes to its regulations for certain high-risk in vitro diagnostics (IVDs). The agency has opened a four-week consultation period to get public feedback on the changes, which, if adopted, could take effect next year.

With some exceptions, IVDs are not allowed on the market without a UK Conformity Assessed (UKCA) marking under the Medical Devices Regulations 2002. Furthermore, the regulation is set to be amended to use a risk-based approach, where devices classified from lowest to highest risk will be classified from A to D. The change incorporates International Medical Device Regulators Forum (IMDRF) principles and the classification system used in the EU. However, that also means the current common technical specifications used to classify devices will no longer be accepted.

“The classification system for IVD devices in [Great Britain] GB will be changing from a predetermined list to a risk-based classification system,” said MHRA. “This means that the common technical specifications for high-risk List A IVD devices will no longer be applicable as the devices will be reclassified as Class D IVD devices. This leaves a gap in regulatory requirements for high-risk IVD devices and poses a risk on patient safety.”

MHRA is proposing three major changes. The first change would be to use common specification requirements to evaluate certain Class D IVDs, so they are consistent with European regulations, particularly EU Commission Implementing Regulation 2022/1107. The agency said the change would ensure it uses a risk-based approach to evaluating the highest-risk tests and conforms to its IVD requirements for Northern Ireland.

“In practice, it would mean that during conformity assessment of certain high-risk IVD devices, Approved Bodies will be required to assess the performance of the IVD in meeting the common specification requirements where no harmonized standard exists,” said MHRA.

MHRA noted that the proposed common specifications set minimum performance requirements and are similar to common technical specifications, which are already used to evaluate certain high-risk IVDs. Common technical specifications currently apply to tests such as those used to test for HIV, hepatitis, blood grouping, and human T-Cell lymphotropic virus.

The second change proposed by MHRA would require using common specification requirements in a Post Market Performance Follow-up (PMPF) Plan. The requirement would take a total product lifecycle approach to diagnostic products and ensure they are monitored for safety and effectiveness after they’ve been allowed on the market.

“In practice, it would mean that during conformity assessment of high-risk IVD devices, approved bodies will be required to assess the PMPF plan and ensure it includes monitoring for common specifications,” the agency added.

Finally, MHRA is also proposing to end 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.  

“In practice, this would mean that an IVD manufacturer planning to place a COVID-19 test device on the Great Britain market would only need to comply with common specifications for SARS-CoV-2 tests and not the Coronavirus Test Device Approvals requirements in the MDR 2002,” said MHRA. “Approved Bodies would be required to assess the performance of the COVID-19 test device in meeting the common specification requirements, rather than the Coronavirus Test Device Approvals assessment currently being managed by MHRA.”

Stakeholders can respond to the consultation questionnaire on MHRA’s website by 14 June.

MHRA announcement

MHRA proposes requirements for high-risk IVDs

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