Lord’s Mark Secures MHRA IVD Registration for UK

Lord’s Mark Secures MHRA IVD Registration for UK

Lord’s Mark Industries Limited announced that its in‑vitro diagnostics (IVD) portfolio has been officially registered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) on September 24, 2026. The registration lists Lord’s Mark as a registered manufacturer and encompasses several IVD categories, specifically haematological cell analysers, multiple clinical chemistry analysers, buffered sample diluents, and instrument/analyser cleaning agents.

This regulatory milestone follows the company’s earlier MHRA registration for its AI‑powered Renalyx haemodialysis system, which was publicised in September 2026 and marked the firm’s initial entry into the UK and allied markets. The new IVD registration expands the international roadmap from renal‑care technology to a broader diagnostics offering, laying the groundwork for a more extensive healthcare presence in the region.

Lord’s Mark plans to begin commercial sales of the newly registered IVD products in the United Kingdom in December 2026, a timeline that is approximately two months ahead of the company’s original schedule. In parallel, the firm intends to launch operations of a pathology laboratory in January 2027, creating an additional platform for diagnostic services and supporting its vision of integrating diagnostic products, laboratory capabilities, and healthcare delivery.

Dr. Sachidanand Upadhyay, MD & CEO of Lord’s Mark Industries Limited, stated: “Our recent MHRA registration for the Renalyx haemodialysis system opened an important door for us in the UK & UK‑allied markets. This latest registration for our IVD portfolio demonstrates that our ambition extends well beyond a single healthcare product. We are building a broader diagnostics and healthcare platform, with commercialisation now planned two months ahead of schedule, followed by the launch of our pathology laboratory in January 2027.”

The UK government requires that medical devices, including IVDs, be registered with the MHRA before they can be placed on the Great Britain market, making this registration a critical step toward commercialisation. Lord’s Mark’s strategy positions the UK as a pivotal international platform while it continues to explore opportunities across other UK‑allied jurisdictions, subject to each jurisdiction’s regulatory requirements.