Regulatory Q&A Forum
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With the European Chemicals Agency (ECHA) expected to release a draft opinion on its comprehensive PFAS restriction proposal, non-EEA manufacturers are increasingly focused on ensuring compliance with...
For a novel Software as a Medical Device (SaMD) intended as a retinal diagnostic software device, what are the key regulatory considerations when building a submission strategy around the pathway defi...
What is the role of Class II Special Controls in the premarket notification (510(k)) process for in vitro diagnostic (IVD) devices, and how should sponsors proactively address them? For many moderate...
As global Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) regulations evolve, with significant new compliance deadlines anticipated around 2026, how should ...
As the 2026 deadlines for various Extended Producer Responsibility (EPR) and Waste Electrical and Electronic Equipment (WEEE) schemes approach, how should medical device manufacturers structure their ...
When planning a biocompatibility program for a medical device, especially with significant updates to recognized international standards anticipated around 2026, what is a comprehensive framework for ...
With significant updates to the ISO 10993 series anticipated to take effect around 2026, medical device manufacturers face the challenge of ensuring their testing strategies align with future regulato...
For non-EU manufacturers intending to place chemical substances on the European market, appointing a REACH Only Representative (OR) is a critical step for compliance. However, selecting the right part...
With the Carbon Border Adjustment Mechanism (CBAM) set for full implementation in 2026, how are the duties of a REACH Only Representative (OR) expected to evolve beyond their traditional scope for non...
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...