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Tissue Regenix Group PLC on Monday said it has received CE and UK Conformity Assessed certification for OrthoPure XT, its biological tendon replacement technology. The Leeds, England-based regenerative medical devices company said the CE certification was obtained under the EU Medical Device Regulation, and the UKCA certification under the UK Medical Device Regulation. The firm noted that OrthoPure XT previously received the CE certification under the EU Medical Device Directive, but that the EU MDR represents recent improvements in standards for the safety and efficacy of medical devices. As part of these certifications, OrthoPure XT has been approved for a 24-month shelf life. This removes barriers to market, will increase adoption among healthcare institutes and will also offer opportunities for new tender bids, hospital contracts and distributor partnerships that require MDR certification, Tissue Regenix said. ‘We are incredibly pleased to have received CE and UKCA certifications for OrthoPure XT. This recognises that our product meets the higher standards and requirements put in place by EU and UK MDR and will open the door for expansion of the OrthoPure product family more efficiently through an established MDR framework,’ said Chief Executive Officer Daniel Lee. ‘Recognition by these regulatory frameworks is also a testament to the group’s ability to successfully execute regulatory transitions and our continued commitment to quality and safety increases customer and clinician confidence in our products.’ Shares in Tissue Regenix were flat at 31.00 pence each in London on Monday morning. The stock is down 55% over the past year. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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