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 […]

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 […]

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 […]

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 MassDevice.com or […]

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 […]

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 […]

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 […]

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially approved new regulations pertaining to registration and commercialization of custom-made devices in the country. 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 […]

By James Keller, Emergo Group That was the tagline for the 2019 Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Philadelphia this September. As a first-time attendee of RAPS convergence, I could relate. However, for me, and I think for many of the other RAPS attendees, it was like drinking from a fire hose while […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions. 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 […]

By Stewart Eisenhart, Emergo Group Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical Devices Regulation (MDR), raising the total number of Notified Bodies with MDR designation to five. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]