By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy. Get the full story here at the […]

By Erin Davis and Benjamin Basseches, Emergo Group Some people might assume that diaries are only used to record the day-to-day trials and musings of teenagers. But – surprise! – diaries (specifically, diary studies) are actually a valuable method to add to your ethnographic research toolkit. Generally speaking, a diary study is a qualitative research […]

By Ronald Boumans, Emergo Group The new Medical Devices Regulation (EU) 2017/745 is not an update of the current Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/382/EEC (AIMDD); it requires all devices to be certified again. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]

By Ronald Boumans, Emergo Group On January 15th, 2019, the UK Parliament voted the Brexit agreement down by a record majority of 432 against 202. The Brexit agreement was the result of negotiations between the EU and the UK negotiators. Previously it had been accepted by EU leaders and the UK government, but required approval […]

By Ronald Boumans, Emergo Group On January 3, the MHRA published guidelines for the situation of a no-deal Brexit. If no agreement is reached, the UK may decide to leave the EU without any deal. Then the UK will become, from the perspective of the EU, a “third country.” Get the full story here at […]

By Ronald Boumans, Emergo Group The UK has voted in a referendum to leave the European Union (EU). The procedure, described in article 50 of the Treaty of the European Union, started on March 30, 2017 and should take two years at a maximum. With less than 100 days to go and the UK Parliament […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has finalized details of a new registration route for breakthrough medical devices first announced in 2017. 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 Stewart Eisenhart, Emergo Group New guidance from Health Canada would establish cybersecurity requirements and considerations for pre-market reviews of devices in Canada similar to policies developed by US and South Korean regulators. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]

By Stewart Eisenhart, Emergo Group Although the first Notified Bodies (NBs) will soon be designated to the European Medical Devices Regulation (EU) 2017/745 (MDR), the New Approach Notified and Designation Organisations (NANDO) database has been updated with a new NB for the current Medical Devices Directive 93/42/EEC, Active Implantable Medical Device Directive 90/385/EEC and In […]

By Stewart Eisenhart, Emergo Group Health Canada has issued a final email reminder to medical device companies regarding the regulator’s December 31, 2018 deadline for transitioning to the Medical Device Single Audit Program (MDSAP) for quality management system compliance. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]