Regulatory Q&A Forum
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As key international consensus standards for the biological evaluation of medical devices are updated, how should manufacturers strategically adapt their biocompatibility programs, not just for new su...
When planning a premarket submission to the FDA, how should a medical device sponsor move beyond a simple checklist mentality to develop a comprehensive and defensible biocompatibility evaluation stra...
With the European Chemicals Agency (ECHA) planning enforcement inspections in 2026 focused on Only Representatives (OR), how can a non-EU manufacturer, such as a medical device company whose products ...
For a novel Class II in vitro diagnostic (IVD) test system—for instance, a prognostic test for liver disease progression regulated under 21 CFR 862.1622 or an acute kidney injury test under 21 CFR 862...
With new Extended Producer Responsibility (EPR) laws for electronics and batteries set to take effect in several US states by 2026, manufacturers of medical devices that fall under these regulations f...
When developing a Class II in vitro diagnostic (IVD) device, how do sponsors determine the applicable "Special Controls," and what role do these controls play in a premarket submission beyond the stan...
As new state-level Extended Producer Responsibility (EPR) laws for electronics are introduced across the United States, medical device manufacturers must prepare for evolving compliance obligations. F...
With significant updates to Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) frameworks expected to take effect by 2026 in key markets like the EU, UK, and N...
With significant updates to the ISO 10993-1 standard anticipated for 2025/2026, how should medical device manufacturers strategically adapt their biocompatibility programs to ensure continued complian...
With the medical device industry anticipating a significant update to the ISO 10993-1 standard for biological evaluation, how should manufacturers strategically revise their approach to demonstrating ...
For medical device manufacturers based outside of Great Britain, appointing a UK Responsible Person (UKRP) is a critical step for market access. As the UK's regulatory framework continues to evolve to...
For Class II medical devices, particularly in vitro diagnostics (IVDs), General Controls are often insufficient to provide a reasonable assurance of safety and effectiveness. To address this, the FDA ...
When preparing a premarket submission for a connected medical device, how should sponsors effectively document their cybersecurity approach to meet FDA's expectations for both Quality System integrati...
With new Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) regulations and deadlines emerging in North America and Europe for 2026, manufacturers of medical d...
With significant updates to the ISO 10993-1 standard anticipated around 2026, medical device manufacturers are re-evaluating their approach to establishing biological safety. How should a sponsor dete...
With significant updates to the international standard for biological evaluation, ISO 10993-1, anticipated around 2026, how should medical device manufacturers adjust their biocompatibility assessment...
As the UK's medical device regulatory framework evolves towards a new compliance deadline in 2026, how should non-UK manufacturers re-evaluate the role and responsibilities of their UK Responsible Per...
As non-UK medical device manufacturers navigate the evolving UK regulatory landscape, how can they develop a robust framework for selecting the most suitable UK Responsible Person (UKRP) to ensure com...
What are the key strategic considerations for a non-EU medical device manufacturer when selecting an EU Authorised Representative (AR) under the Medical Device Regulation (MDR)? The MDR mandates that ...
For non-EU medical device manufacturers aiming to place products on the European market, selecting the right EU Authorised Representative (AR) is a critical compliance step under the Medical Device Re...