By Stewart Eisenhart, Emergo Group A new discussion paper from the US Food and Drug Administration identifies challenges to developing effective regulatory oversight of 3D printed medical devices used in patient point of care (PoC) settings, and lays out potential regulatory approaches for such devices. Get the full story here at the Emergo Group’s blog. […]

By Stewart Eisenhart, Emergo Group The U.S. Food and Drug Administration has set a 2.5% increase for 2022 fiscal year fees charged to medical device market applicants seeking 510(k) clearance, Premarket Approval (PMA), De Novo or other registrations in order to sell their products on the US market. Get the full story here at the […]

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 […]

By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. 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 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 […]

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 […]

By Ronald Boumans, Emergo Group Based on the current course of the UK’s planned withdrawal from the European Union by the end of 2020, an examination of how medical device market entry in Northern Ireland will be impacted is due. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

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 […]

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 […]

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 […]