MHRA registration received for IVD portfolio; UK commercial sales planned from December 2026

IVD portfolio registered with the UK's MHRA (dated September 24, 2026) — covers haematological cell analysers, clinical chemistry analysers, diluents and cleaning agents.

Mon 5 Oct 2026

MHRA Registration Date

September 24, 2026

UK Commercial Sales Planned

December 2026, approximately two months ahead of the earlier schedule

Pathology Lab Operations Planned

January 2027

Categories Covered

haematological cell analysers, clinical chemistry analysers, buffered sample diluents, instrument/analyser cleaning agents

What was registered

The IVD (in-vitro diagnostics) portfolio has been registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA), with the registration dated September 24, 2026. The registration records the company as a registered manufacturer.

The categories covered include

• haematological cell analysers
• multiple clinical chemistry analysers
• buffered sample diluents
• instrument/analyser cleaning agents

What is planned next

• Commercial sales of the IVD products in the UK are planned from December 2026, approximately two months ahead of the earlier schedule.
• Operations of the pathology laboratory are planned from January 2027.
• The company intends to pursue opportunities across UK-allied markets, subject to applicable regulatory requirements in each jurisdiction.

Why this registration matters

The update notes that the UK government states medical devices, including IVDs, must be registered with MHRA before they can be placed on the Great Britain market, making the registration an important regulatory step towards commercialisation.

The wider context

This follows the earlier MHRA registration for the company's AI-powered Renalyx haemodialysis system, announced in September, which marked its planned entry into the UK and UK-allied markets. The update describes the successive registrations as broadening that roadmap from renal-care technology to diagnostics.

The company frames the December 2026 commercialisation and the January 2027 pathology-lab launch as an integrated healthcare strategy bringing together IVDs, advanced medical technology and diagnostic services, rather than a single-product market entry.

What investors can note

• These are stated plans, with December 2026 for IVD commercial sales and January 2027 for the pathology laboratory.
• The UK market is described as an important international platform, with UK-allied markets being pursued subject to each jurisdiction's regulatory requirements.

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