MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the future of regulatory oversight with the launch of the AI Airlock initiative, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD). This groundbreaking endeavor marks a significant leap forward in harnessing the […]
MHRA Proposes Stringent Requirements for High-Risk In Vitro Diagnostic Devices (IVDs)
In a bid to bolster patient safety and enhance regulatory oversight, the Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled proposed requirements for high-risk in vitro diagnostic devices (IVDs) in the United Kingdom. The proposed measures, outlined in a recent consultation document, represent a significant step towards aligning UK regulatory standards with international best […]
The MHRA Roadmap: Navigating the UK Market
While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition: Additionally, self-declared CE-marked […]
