Regulatory Q&A Forum
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Foreign medical device establishments are required to designate a U.S. Agent to serve as their official point of contact with the FDA. With the new Quality Management System Regulation (QMSR) becoming...
When evaluating "Person Responsible for Regulatory Compliance (PRRC) as a Service" under the EU MDR, how can manufacturers move beyond a simple price tag to accurately assess the total cost and value?...
For medical device startups navigating the European market, appointing a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under EU MDR Article 15. Given that hiring a ful...
As medical device manufacturers plan their compliance strategies for 2026 and beyond, how can they develop a robust framework for selecting an external 'Person Responsible for Regulatory Compliance (P...
When a non-EU manufacturer seeks to appoint a REACH Only Representative (OR) to comply with Regulation (EC) No 1907/2006 (REACH), what comprehensive framework of due diligence should be employed to en...
With the ECHA Forum announcing a pilot project in 2026 to inspect the compliance of Only Representatives (ORs), how should non-EU manufacturers of chemical substances re-evaluate their selection proce...
For sponsors developing a novel Class II in vitro diagnostic (IVD), such as a pharmacogenetic assessment system or a mass spectrometry-based test, what are the key factors in determining the necessary...
For non-EU medical device manufacturers, what is the role and strategic importance of the European Authorised Representative (AR) under the EU Medical Device Regulation (MDR), and what key qualificati...
When are Special Controls required for a Class II medical device, and how do they build upon General Controls to ensure safety and effectiveness? All medical devices marketed in the U.S. are subject ...
With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic product manufacturers and processors face a new critical requirement: appointing a United States Agen...
For foreign cosmetic establishments, the Modernization of Cosmetics Regulation Act (MoCRA) introduces a mandatory requirement to designate a United States Agent. But beyond fulfilling a line item on a...
When budgeting for 2025, how can medical device manufacturers effectively evaluate the true cost and value of outsourcing the Person Responsible for Regulatory Compliance (PRRC) role? Beyond a standar...
When evaluating external providers for the Person Responsible for Regulatory Compliance (PRRC) role under the EU Medical Device Regulation (MDR), manufacturers often discover that the cost is not a si...
For non-EU medical device manufacturers, navigating the complexities of the EU REACH regulation for substances like Per- and Polyfluoroalkyl Substances (PFAS) presents a significant compliance challen...
With the European Chemicals Agency (ECHA) planning targeted inspections of Only Representatives (ORs) in 2026 under its REF-14 enforcement project, how can non-EU manufacturers move beyond a simple ch...
For manufacturers of legacy medical devices previously compliant under the Medical Device Directive (MDD), the transition to the EU Medical Device Regulation (MDR) presents significant challenges, esp...
When developing a 510(k) submission for a Class II in vitro diagnostic (IVD) device, how should a sponsor effectively identify, interpret, and demonstrate conformity with applicable special controls? ...
As manufacturers of electronic products, including medical devices with electronic components, prepare for new Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EP...
When developing a novel retinal diagnostic software device intended to fall under the classification regulation 21 CFR 886.1100, what are the critical factors for determining if the device's specific ...
When a medical device manufacturer plans its 2026 compliance budget, outsourcing the role of the Person Responsible for Regulatory Compliance (PRRC) is a key consideration. However, determining the co...