By Stewart Eisenhart, Emergo Group The European Medicines Agency (EMA), which oversees the European Union’s pharmaceutical market, has begun rolling out guidance and clarifications regarding Medical Devices Regulation (MDR) compliance issues for manufacturers of combination products with drug and medical device components. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
blog
How IoT is affecting connected medical device designs
By Joe Fegelman and Natalie Shortt, Emergo Group In the established landscape of the design of digital products, software and UI/UX design is generally broken down into two formats: desktop and mobile. For years, user interactions with “connected” medical devices have revolved around PCs and, more recently, mobile phones and smart televisions. Get the full […]
FDA issues final Q-Submission guidance to include medical device cybersecurity coverage
By Stewart Eisenhart, Emergo Group Finalized US Food and Drug Administration guidance for its Q-Submission (Q-Sub) Program whereby manufacturers solicit feedback from the agency prior to submitting their premarket applications now includes recommendations for cybersecurity-related issues. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Canadian regulators recommend 3D-printed medical device license applicants
By Stewart Eisenhart, Emergo Group Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices regarding what to include in their Medical Device License (MDL) applications and commercialize 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 […]
Regulatory updates from Brazil ANVISA
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements. Below, we’ve compiled several important Brazilian market and […]
Latest Brexit extension raises more questions for U.K. and European medical device industries
By Stewart Eisenhart, Emergo Group The British government has asked for – and the EU Member States unanimously agreed to– a further extension of the article 50 procedure, by which a Member State can leave the EU in two years’ time. The previous date had been set at March 29th, then it was extended until […]
Japan regulators extend MDSAP participation
By Stewart Eisenhart, Emergo Group The Japanese Ministry of Health, Labour and Welfare (MHLW) is extending the country’s participation in the Medical Device Single Audit Program through early 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 not necessarily reflect […]
New MDCG guidance on timelines and legacy device in Eudamed
By Ronald Boumans, Emergo Group New guidance from European regulators addresses data entry timelines for the Eudamed medical device database, as well as how to develop and assign Unique Device Identification (UDI) data for “legacy devices.” Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Egypt fast-track medical device registration pathway speeds up market access timeframes
By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying 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 those of DrugDeliveryBusiness.com […]
U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]