Regulatory Q&A Forum
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When developing a Class II in vitro diagnostic (IVD) test system, how do sponsors navigate the interplay between a device’s classification regulation and its corresponding Class II Special Controls Gu...
When developing a novel in vitro diagnostic (IVD) test system, how do sponsors determine the appropriate regulatory controls and submission requirements, particularly when the device falls into Class ...
With significant updates to Extended Producer Responsibility (EPR) and Waste from Electrical and Electronic Equipment (WEEE) regulations anticipated across various jurisdictions for 2026, medical devi...
Given the significant updates to global Extended Producer Responsibility (EPR) and Waste from Electrical and Electronic Equipment (WEEE) regulations anticipated around 2026, how should a medical devic...
With ongoing discussions in the industry regarding future biocompatibility standards, including potential updates to the ISO 10993 series, how can medical device manufacturers develop a robust strateg...
With significant updates to global biocompatibility standards anticipated around 2026, how should medical device manufacturers strategically re-evaluate their biological safety assessment plans to ens...
With key UK regulatory deadlines approaching in 2026, non-UK based medical device manufacturers must appoint a UK Responsible Person (UKRP) to place devices on the Great Britain market. Beyond simply ...
For medical device manufacturers based outside of Great Britain, appointing a UK Responsible Person (UKRP) is a mandatory step for market access. However, selecting the right partner involves more tha...
When FDA classifies an in vitro diagnostic (IVD) device as Class II, it signifies that general controls alone are insufficient to provide a reasonable assurance of safety and effectiveness. Consequent...
With the significant 2026 French VAT reforms on the horizon, particularly the phasing out of the 'Regime 42' simplification for non-EU businesses, many companies are now facing the mandatory requireme...
For a medical device manufacturer preparing for evolving Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) obligations with 2026 deadlines approaching, what i...
With significant updates to Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) regulations anticipated for 2026 across the EU, UK, and various US states, how s...
With potential new global biocompatibility standards being discussed for 2026, which may not be immediately adopted by the FDA, how can medical device manufacturers develop a robust and defensible bio...
How can medical device manufacturers perform due diligence to select a biocompatibility testing laboratory that is prepared for evolving international standards, such as future updates to the ISO 1099...
What are the core requirements for a UK Responsible Person (UKRP) as Great Britain’s medical device regulations continue to evolve? For medical device manufacturers based outside the UK, appointing a...
With the UK's post-Brexit regulatory framework for medical devices continuing to evolve, what are the key responsibilities and strategic considerations for manufacturers when appointing and managing a...
When budgeting for an EU Responsible Person (RP) to meet cosmetic compliance deadlines, what key factors and service models determine the overall cost? Rather than a single fixed price, the investment...
When developing a novel Class II in vitro diagnostic (IVD) device that utilizes an AI/ML algorithm to aid in risk assessment or prognosis, what are the intersecting regulatory expectations for both th...
When medical device manufacturers plan to place electrical or electronic products on the European market, establishing compliance with the Waste Electrical and Electronic Equipment (WEEE) Directive an...
For manufacturers of medical devices also classified as Electrical and Electronic Equipment (EEE), navigating environmental compliance schemes like WEEE (Waste Electrical and Electronic Equipment) and...