By Ronald Boumans, Emergo Group UDEM Adriatic d.o.o., based in Zagreb, Croatia, is a new name in the EU Notified Body community. They have been officially listed in the European database for Notified Bodies, NANDO, designated for the upcoming Medical Devices Regulation (EU) 2017/745 (MDR). Their Notified Body number is 2696. UDEM is not listed […]
Regulatory/Compliance
Clinical study sponsors may become non-EU post-Brexit
By Ronald Boumans, Emergo Group The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and […]
Canada approves Abbott Freestyle Libre 2 for adults and children
Abbott (NYSE:ABT) announced that Health Canada has approved its FreeStyle Libre 2 continuous glucose monitor for adults and children. The next-generation, wearable, sensor-based CGM technology with real-time alarms is approved for use in adults and children (four years old and up) and will be priced the same as the current FreeStyle Libre system, according to a […]
Key steps for medical device manufacturers effective CAPA management
By Sarah Fitzgerald and Stewart Eisenhart, Emergo Group Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers. Get the full story here at […]
Baxter wins Canadian clearance for infusion system
Baxter (NYSE:BAX) Canada announced today that it received Health Canada authorization for its Novum IQ infusion platform. Novum IQ received marketing authorization for its large volume pump and syringe infusion pumps, as well as Mississauga, Ontario-based Baxter Canada’s Dose IQ safety software. Baxter expects Novum IQ to be available to Canadian customers in the coming weeks, […]
MDSAP council updates guidance on conformity assessments and related requirements
By Timothy Herr, Emergo Group Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document into a single source of information detailing the process for auditing the quality management systems of medical […]
What you need to know about analytical testing for drug-device combinations
Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system. Jennifer Riter, West Pharmaceutical Services As more pharmaceutical manufacturers develop combination products, they identify new and complex interactions among packaging components and delivery systems. Understanding this interplay is critical to developing a successful […]
Chinese regulators delay medical device UDI implementation
By Stewart Eisenhart, Emergo Group China’s National Medical Products Administration (NMPA) has extended the trial period for its medical device unique device identification (UDI) program in response to the coronavirus pandemic, pushing first-round UDI implementation requirement deadlines to early 2021. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
MDR mutual recognition agreement unresolved after Swiss referendum
By Ronald Boumans, Emergo Group On September 27, 2020, the Swiss held one of their many referendums. Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before […]
Abbott’s FreeStyle Libre 3 receives CE Mark
Abbott (NYSE:ABT) has won the CE Mark in the European Union for its next-generation FreeStyle Libre 3 continuous glucose monitoring system. Officials at Abbott boast that the Libre 3 technology includes a super small, thin sensor. It’s the size of two U.S. pennies stacked together and able to accurately provide real-time glucose readings over 14 days […]
