Today, a clear path ahead has been 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 ...
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...
Today, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, announced a proposed framework for the ...
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