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UK Publishes Proposed Framework for Recognizing IVDs Cleared Elsewhere

NEW YORK – The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

These "comparable regulatory countries," as they are called in MHRA's statement of policy intent, include the US, the European Union, Canada, and Australia. The policy released on Tuesday provides a regulatory framework for IVD manufacturers who have already obtained regulatory clearance for their tests via the US Food and Drug Administration, Health Canada, or the Australian Therapeutic Goods Administration, or that obtain a CE-IVD mark in the EU and European Economic Area, to place their products on the UK market in the future without going through a submission process with the MHRA.

According to the MHRA, such tests need to comply with the relevant legislation in a comparable regulatory country; have English labeling and packaging; comply with British requirements for electronics and voltage, as well as units of measurement; have a UK responsible person included on the label; have relevant unique device identifiers; and must comply with new post-market surveillance requirements as stipulated in the UK Medical Devices Regulations that are expected to come into force later this year.

The MHRA also stated that the proposed framework would provide a certificate of international recognition that will grant devices access to the market in England, Scotland, and Wales, but would not provide a UK Conformity Assessed marking or UKCA certification.

There are some categories of devices that would be excluded from the proposed framework. These include in-house and custom-made devices; software as a medical device product that doesn't satisfy MHRA intended purpose guidelines; companion diagnostics and combination products relating to medicinal substances not licensed in the UK; and several other groups.

In its statement of policy intent, MHRA also outlined different access routes to the UK market according to the class of the device cleared by the authorities on comparable regulatory countries and addresses the Northern Ireland market, where CE-IVD marked goods can continue to be placed indefinitely.

MHRA noted that the proposed framework is a draft and said the final version would come into force at the same time as the future core regulations, which are scheduled to be in force in 2025.

In a statement also released on Tuesday, the British In Vitro Diagnostics Association, which represents UK IVD makers, released a statement welcoming MHRA's statement of policy intent. 

In it, BIVDA said it had been "heavily involved" as an adviser to the MHRA and had been working with the approved bodies — standards organizations that are designated by the state to assess the conformity of devices to regulations — as well as BIVDA's UKCA working group. BIVDA said it made a detailed policy submission to MHRA as part of this process.

Mike Messenger, BIVDA's head of regulatory strategy, said the association "welcomes this new initiative from MHRA to adopt a smart framework for reliance and recognition." He said it was "in line with international best practice principles to increase regulatory efficiency and to ensure continued patient access to safe and effective IVDs."

According to Messenger, such a policy will be complementary to the country's UKCA framework, along with "proportionate premarket access requirements and robust post-market surveillance." This could also encourage domestic companies to get their tests cleared in the UK first before entering other markets.

"This will position UKCA as a global mark of quality and enhance the attractiveness of the UK as a destination for IVD development, manufacturing, evaluation, and launch," Messenger said.