By Ronald Boumans, Emergo Group On October 30, 2018 the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20 replaces version 1.19 released in April 2018. Get […]
FDA updates UDI policy for direct marking of medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has revised its Unique Device Identification (UDI) regulation’s direct mark requirements and compliance deadlines in response to cost and inventory concerns raised by industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
EU MDR and IVDR implementations still on track
By Ronald Boumans, Emergo Group The European Commission reports that implementation efforts for the EU Medical Devices Regulation (MDR) 2017/45 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 remain on track, as well as related efforts regarding Notified Body designations and Eudamed database development. Get the full story here at the Emergo Group’s blog. […]
Saudi regulators adjust MDMA submission timeframe
By Stewart Eisenhart, Emergo Group Medical device regulators at the Saudi Food and Drug Authority (SFDA) have updated deadlines for pending Medical Device Market Application (MDMA) 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 […]
What a draft Brexit agreement means for the medical device industry
By Ronald Boumans, Emergo Group British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU). 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 […]
ANVISA report shows increase in medical device modification submissions
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has reported a major increase in medical device modification applications received over the past three months compared to the first half of 2018 following changes to importation and inspection requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
South Korean medical device regulators to align quality requirements with ISO 13485:2016
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has issued draft plans to align Korea Good Manufacturing Practice (KGMP) more closely to the ISO 13485:2016 medical device quality system standard. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
FDA clears 23andMe for pharmacogenetics testing
The FDA recently cleared a pharmacogenetic DNA test from 23andMe that is designed to determine how users will react to certain pharmaceutical drugs. The FDA cleared the new 23andMe test to give information on 33 genetic variants that determine how patients will respond to more than 50 different prescribed and over-the-counter medications. The test, which […]
OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement
OsteoRemedies recently announced that it has received FDA clearance for its Remedy Spectrum GV hip spacer system and Spectrum GV bone cement. The system is designed to give surgeons a broad spectrum of treatment options with both Gentamicin and Vancomycin. “We are very proud to have the first FDA cleared dual-antibiotic spacer system and bone […]
FDA committed to studying breast implant safety
By Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of […]