By Ronald Boumans, Emergo Group The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt-out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR), with ongoing lack of resolution regarding Brexit continuing to have an impact as well. Get the full story here at the Emergo […]
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European Commission clarifies medical device vigilance requirements
By Stewart Eisenhart, Emergo Group The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). 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 […]
How human factors validation investigators identify user groups and populations
By Ella Engels, Emergo Group Imagine you are preparing for a human factors (HF) validation study to bring your medical device to market, and the market research recruiters inform you that it will be very challenging, if not unfeasible, to recruit the required 15 participants per user group. What do you do? Get the full […]
European Commission publishes guidance on responsible person requirements under MDR, IVDR
By Stewart Eisenhart, Emergo Group European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). 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 […]
China NMPA releases new eRPS medical device registration system details
By Stewart Eisenhart, Emergo Group Emergo by UL has learned additional details regarding the China National Medical Product Administration’s (NMPA) new electronic medical device registration management (eRPS) system. 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 […]
FDA issues final rule for appealing medical device regulatory decisions
By Stewart Eisenhart, Emergo Group A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Australia regulators publish guidance on recognized QMS standards
By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
South Korean regulators establish new regulations for IVD devices
By Stewart Eisenhart, Emergo Group The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
South Korea trade group, Emergo partnered for medical device RA/QA support
By Stewart Eisenhart, Emergo Group The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies. Get the full story here at the Emergo Group’s blog. The […]
FDA ends medical device Alternative Support Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
