By Stewart Eisenhart, Emergo Group
The FDA has published new guidance on reporting and notification requirements to better mitigate supply disruptions when medical device manufacturers cease or suspend production during public health emergencies.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Stewart Eisenhart, Emergo Group
A new discussion paper from the US Food and Drug Administration identifies challenges to developing effective regulatory oversight of 3D printed medical devices used in patient point of care (PoC) settings, and lays out potential regulatory approaches for such devices.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Stewart Eisenhart, Emergo Group
The U.S. Food and Drug Administration has set a 2.5% increase for 2022 fiscal year fees charged to medical device market applicants seeking 510(k) clearance, Premarket Approval (PMA), De Novo or other registrations in order to sell their products on the US market.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Stewart Eisenhart, Emergo Group
The European Commission has published a new factsheet explaining how the upcoming Medical Devices Regulation (EU) 2017/745 (MDR) will affect manufacturers of low-risk Class I medical devices.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Timothy Herr, Emergo Group
Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available. These are compiled from various announcements and guidance documents (all links in Chinese) published by the Taiwan Food and Drug Administration (TFDA). Unless otherwise specified, these changes will go into effect with the law on May 1. One of the key documents included in this roundup is a draft fee schedule.
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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
The European Commission’s Medical Device Coordinating Group (MDCG) has issued new guidance explaining the role of safety and performance standards under current Medical Device Directives as well as the upcoming Medical Devices Regulation (MDR) and In-vitro Medical Devices Directive (IVDR).
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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
Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Stewart Eisenhart, Emergo Group
The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Dietmar Falke, Emergo Group
The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing sufficient clinical evidence.”
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
By Timothy Herr, Emergo Group
China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
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.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.
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 are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.