Regulatory Q&A Forum
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With the European Chemicals Agency (ECHA) announcing a pilot project focusing on Only Representative (OR) inspections in 2026, non-EU manufacturers face increased pressure to ensure their appointed OR...
When preparing a 510(k) submission for a connected medical device, such as a wearable cardiac monitor or a clinical electronic thermometer with wireless capabilities, how should sponsors approach cybe...
For medical device manufacturers placing products on the market in jurisdictions with Extended Producer Responsibility (EPR) schemes, selecting an appropriate representative for Waste Electrical and E...
Given the clarifications in the December 2023 MDCG guidance on the role of the Person Responsible for Regulatory Compliance (PRRC), how should medical device manufacturers, particularly small or micro...
With the European Chemicals Agency (ECHA) Forum announcing a pilot project focusing on Only Representatives (ORs) and planning inspections for 2026, non-EU manufacturers face increased pressure to ens...
When a U.S.-based manufacturer of a Class II in-vitro diagnostic (IVD) device, such as an acute kidney injury test system regulated under 21 CFR 862.1220, plans for commercial distribution in the Euro...
As medical device manufacturers prepare for significant updates to WEEE (Waste Electrical and Electronic Equipment) and EPR (Extended Producer Responsibility) regulations taking effect through 2026, h...
As regulatory expectations for biocompatibility continue to evolve, how should a medical device manufacturer prepare a biological evaluation strategy for a device intended for submission in 2026? For ...
For manufacturers of complex in vitro diagnostic (IVD) platforms, what is the regulatory thought process for delineating the classification and submission requirements for the various system component...
For medical device manufacturers developing software-enabled devices, how can they effectively demonstrate a robust cybersecurity posture in a premarket submission by integrating threat modeling with ...
Given the increasing integration of network connectivity in medical devices, how should sponsors of products like an integrated continuous glucose monitoring system (as described in 21 CFR 862.1355) o...
With the upcoming revision to ISO 10993-1 expected in 2025, how should medical device manufacturers strategically update their biological evaluation approach for both new and existing devices? Beyond ...
With the transitional arrangements for medical devices in Great Britain requiring a UK Responsible Person (UKRP) to be appointed, what is a comprehensive framework for a non-UK manufacturer to select,...
With the planned 2026 phase-out of France's VAT Regime 42, many non-EU businesses importing goods into the EU via France will face a new requirement: appointing a VAT fiscal representative. This intro...
Given the significant updates to WEEE and EPR (Extended Producer Responsibility) regulations anticipated for 2026, how should a manufacturer of electronic medical devices strategically evaluate and se...
As international consensus standards for biocompatibility evolve, medical device sponsors face the challenge of selecting testing partners who are not only compliant today but also prepared for future...
Given the evolving UK medical device regulations and the approaching 2026 deadline for manufacturers to formalize their UK Responsible Person (UKRP) arrangements, how can a non-UK based manufacturer m...
For Class II medical devices, what are "Special Controls," and how do they function within the FDA 510(k) framework? While all medical devices are subject to General Controls (e.g., establishment regi...
Given the significant updates to Extended Producer Responsibility (EPR) and Waste Electrical and Electronic Equipment (WEEE) regulations anticipated across the EU for 2026, what comprehensive framewor...
With significant updates to key international standards like ISO 10993-1 anticipated around 2026, how can medical device manufacturers effectively evaluate a biocompatibility testing laboratory's read...