By Timothy Herr, Emergo Group While we have reported on the one-year delay of Europe’s Medical Devices Regulation (MDR) due to the COVID-19 pandemic, we have not yet touched on the ramifications that this decision has on countries outside the European Union. The United Kingdom and the nations of the European Free Trade Association (EFTA) […]

By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]

By Ronald Boumans, Emergo Group The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official […]

By Richard Featherstone, Emergo Group The third edition of international standard ISO 14971 (Medical devices—application of risk management to medical devices) is now available. This third version, dated December 2019, cancels and replaces the second edition (ISO 14971:2007). There are a number of changes, some of which relate directly to usability. ISO 14971:2019 is recognized […]

By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into […]

By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) published Announcement No. 99 of 2019, a guidance document intended to clarify the principles employed by the National Medical Products Administration (NMPA) for determining medical device generic names. This expands upon the rules previously outlined in CFDA Order No. 19. (The China Food […]

By Timothy Herr, Emergo Group On February 17, Singapore’s Health Sciences Authority (HSA) published a number of revised guidance and technical reference documents. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

By Stewart Eisenhart, Emergo Group Health Canada, Canada’s medical device market regulator, has begun accepting some clinical trial-related information from sponsors via electronic submissions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its […]

By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]

By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]