US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning
FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.
IVD Devices: From Performance Evaluation Studies to Clinical Performance Studies, What has Changed?
For the marketing of in vitro diagnostic (IVD) medical devices manufacturers need to demonstrate that their products perform as claimed, which typically requires performance data obtained from appropriate studies or from available state-of-the-art literat
Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices
Singapore's health sciences authority (HSA) has issued final guidance on unique device identification (UDI) rules for medical devices and IVDs, with a phased implementation timeline for compliance. Learn more at Emergo by UL.
20th Notified Body Designated Under EU MDR While IVDR Designations Lag
Progress on Notified Body designation continues to raise IVDR capacity concerns
New Guidelines Published on Integrating UDI Into Quality Management Systems Under MDR, IVDR in Europe
The European Medical Device Coordination Group (MDCG) has published new recommendations for medical device manufacturers on integrating Unique Device Identification (UDI) data into their quality management systems
Proposed US FDA Program Targets Medical Device Supply Chain Shortages
A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but would also entail additional compliance work for manufacturers.
Eudamed Update: Additional Data Entry Modules Now Online for European Medical Device, IVD Registrants
European Commissioners have launched additional modules for the Eudamed medical device and in vitro diagnostic (IVD) product database developed to improve European market transparency.
2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering
Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.
Regulators Issue Good Machine Learning Practice Guiding Principles for AI/ML Medical Device Development
Recommendations for developing and testing AI/ML models for medical devices, from US FDA, UK MHRA and health Canada. Learn more at Emergo by UL.
UK MHRA Issues Post-Brexit Medical Device, IVD Registration Requirements
UK regulators clarify post-Brexit registration requirements and deadlines for medical devices, IVDs and related healthcare products. Learn more about UK medical device and IVD regulations at Emergo by UL.