NEWS
MHRA publishes regulatory ‘roadmap’ for medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a regulatory ‘roadmap’, pointing the way ahead for new measures to support safe access to medical technology including AI and diagnostics.
The new document
provides an update on the intended timelines to implement the future core regulations, as outlined in the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE marked devices placed on the Great Britain market which were put in place in 2023.
In the new document, Roadmap
towards the future regulatory framework for medical devices, a clear path is set out for the development of new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that patients continue to have access without delay to
the devices they need, whilst enhancing the UK’s position as a world- leading environment for medical technology innovators. It will enhance the UK’s ability to benefit from rapidly advancing medical technology, offering significant new opportunities for patients and healthcare. Transformative technologies such as new implantable devices, healthcare AI and
software, and diagnostics for early detection and prevention of disease, all demand a new regulatory framework. The MHRA’s roadmap sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.
The planned regulations are also designed to deliver greater international harmonisation, with more patient- centred, proportionate requirements for medical devices which are responsive to technological advances.
bioMérieux bolsters software portfolio with LUMED acquisition
bioMérieux has announced the acquisition of LUMED, a software company that has developed a clinical decision support system to help hospitals optimise antimicrobial prescriptions and monitor healthcare-associated infections. The two companies have been working closely together since 2017 and bioMérieux has acquired the entire share capital of the Canadian firm, increasing its stake from 16% to 100%. The acquisition of 84% of the capital represents an investment close to €9 million. LUMED’s advanced software solutions help ensure that local antimicrobial prescription guidelines are followed and implemented. It gives healthcare professionals all the varied and relevant information they need to optimise their
antimicrobial stewardship and infection prevention and control, to provide better care for their patients, combat antimicrobial resistance and improve infection control.
“For bioMérieux, it is essential that we extend the scope of diagnostic testing beyond the laboratory itself. Today, many hospitals around the world are structuring themselves around the major issue of antimicrobial resistance and infection prevention. With LUMED, we provide solutions for antimicrobial stewardship teams to improve their daily workflow. The software contributes to optimising the process of care delivery, as well as costs and patient management,” declared Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux.
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