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 […]
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FDA recognizes latest ISO 14971 as medical device consensus standard
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 […]
FDA details framework for abbreviated 510(k) medical device review pathway
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 […]
Indian CDSCO announces medical device, IVD regulatory updates
By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic products. 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 […]
EU regulators clarify Notified Body requirements ahead of MDR
By Stewart Eisenhart, Emergo Group The European Medical Device Coordinating Group (MDCG) has updated a Question and Answer resource document covering compliance requirements related to Notified Bodies and joint assessments under the upcoming Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story here at the Emergo Group’s blog. The […]
EU MDCG weighs in on medical device certification issues
By Ronald Boumans, Emergo Group On October 4, the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market […]
How to improve usability for wearable injector devices
By Andrew Micek, Emergo Group A new article provides step-by-step tips to help wearable injector medical device manufacturers improve design and reduce common use errors. 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 DrugDeliveryBusiness.com or […]
DEKRA appointed first Notified Body to European IVDR
By Ronald Boumans, Emergo Group It had already been hinted at the MDCG Stakeholders meeting of September 30th, 2019, but now it is official: DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Get the full story here at the […]
FDA recommendations for URGENT/11 medical device cybersecurity vulnerabilities mitigation
By Stewart Eisenhart, Emergo Group Following recent identification of cyber vulnerabilities in third-party software utilized by some medical devices for network communications, the US Food and Drug Administration has issued several recommendations to manufacturers, healthcare providers and patients to manage and mitigate risks stemming from these vulnerabilities. Get the full story here at the Emergo […]
European MDCG posts guidance on MDR Summary of Safety and Clinical Performance
By Ronald Boumans, Emergo Group The European Commission has issued new guidance for manufacturers of implantable medical devices to develop Summaries of Safety and Clinical Performance (SSCP) based on Medical Devices Regulation (MDR) requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
