Tag: MDR

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 2023
Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

October 5, 2023
Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with preparation...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

EU MDR Regulations

November 22, 2022
Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices,...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR