By Stewart Eisenhart, Emergo Group A new factsheet from the European Commission advises healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story […]
Emergo Group
Brazil ANVISA modifies custom-made medical device regulations
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
LRQA to withdraw European Notified Body medical device and IVD manufacturers services
By Ronald Boumans, Emergo Group UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019. 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 […]
European regulators assign UDI issuing agencies
By Ronald Boumans, Emergo Group The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements. 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 […]
Global medical device regulatory trends
By Evangeline Loh, Emergo Group In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified themes. 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 […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. 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 […]
Chinese authorities update regulatory guidelines
By Stewart Eisenhart, Emergo Group China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. 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 […]
India regulators list risk classifications for 12 notified medical devices
By Stewart Eisenhart, Emergo Group The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020. 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 […]
FDA readies for SaMD Pre-Cert program test cases
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical device (SaMD). 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 […]
TÜV Süd becomes second Notified Body to European MDR
By Ronald Boumans, Emergo Group TÜV Süd is now the second Notified Body designated to issue CE Mark certifications under the upcoming European Medical Devices Regulation (MDR). 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 […]