The EU AI ACT: Implications for the Medical Device Industry
The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]
ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs
In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first lawsuit in an attempt to block the implementation of the Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs). The contentious Final Rule, which aims to regulate LDTs, has sparked heated debates within the healthcare and regulatory […]
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 […]
