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 […]
Emergo Group
Ensuring safe and effective distribution of COVID-19 vaccines
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 […]
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 […]
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 […]
How UKNI will mark medical devices placed on the market in Northern Ireland after Brexit
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 […]
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 […]
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 […]
Japan PMD Act revises fast-track reviews for some medical devices, IVDs
By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA updates final guidance on ISO 10993 for medical device biocompatibility
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices. The updated guidance replaces guidance the agency had finalized in 2016 that emphasized biological evaluations in conjunction with risk management considerations for […]
India regulators propose medical device, IVD extensive risk classification lists
By Stewart Eisenhart, Emergo Group Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
