Regulatory Q&A Forum
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I'm a cosmetics manufacturer based outside the EU. I've heard about Responsible Person requirements under EU Cosmetics Regulation but I'm not sure if they apply to my situation. Can you explain what a...
I'm a medical device manufacturer based outside the UK. I've heard about UK RP requirements under UK MDR 2002 but I'm not sure if they apply to my situation. Can you explain what a UK Responsible Pers...
I'm a medical device manufacturer based outside the EU. I've heard about EC REP requirements under EU MDR/IVDR but I'm not sure if they apply to my situation. Can you explain what an EU Authorized Rep...
I'm a medical device manufacturer looking to enter the Swiss market. I've heard about CH-REP requirements but I'm not sure if they apply to my situation. Can you explain what a Swiss Authorized Repres...
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...
When planning budgets for 2026, how can a medical device manufacturer accurately forecast the investment for an external "Person Responsible for Regulatory Compliance (PRRC) as a Service" under the EU...
When engaging a third-party provider for the Person Responsible for Regulatory Compliance (PRRC) role under the EU Medical Device Regulation (MDR), what key factors typically determine the service cos...
For a small or micro-enterprise navigating the EU MDR, securing a Person Responsible for Regulatory Compliance (PRRC) can be a significant operational and financial consideration. While outsourcing th...
As European authorities advance the proposal to restrict Per- and Polyfluoroalkyl Substances (PFAS) under REACH, how should a non-EU manufacturer, particularly one producing complex articles like medi...
With the European Chemicals Agency (ECHA) expected to advance its opinion on a broad PFAS restriction, non-EU manufacturers face significant challenges in maintaining market access. For companies whos...
While the cost of retaining a REACH Only Representative (OR) can vary significantly, what are the key factors that non-EU manufacturers should evaluate to understand the potential scope and cost of th...
With the 2026 implementation of new French VAT e-invoicing and e-reporting mandates, and the corresponding elimination of certain import mechanisms like Regime 42, many non-EU businesses will be requi...
When developing a novel pharmacogenetic assessment system, which generally falls under regulations like 21 CFR § 862.3364, what is a comprehensive strategy for proactively identifying and addressing t...
When preparing a premarket submission for a connected medical device, such as a networked cardiac monitor, what are the key components of cybersecurity documentation that the FDA generally expects to ...
When a non-U.S. medical device manufacturer plans to enter the U.S. market, appointing a U.S. Agent is a mandatory regulatory requirement. However, the role and value of a U.S. Agent can vary signific...
For manufacturers of electronic medical devices, navigating international markets involves more than just clinical and performance data for regulatory clearance; it also includes complex, region-speci...
For medical device manufacturers placing products on the market in jurisdictions with Extended Producer Responsibility (EPR) and Waste Electrical and Electronic Equipment (WEEE) regulations, appointin...
As the EU's Waste from Electrical and Electronic Equipment (WEEE) Directive and Extended Producer Responsibility (EPR) frameworks evolve, with significant revisions anticipated around 2026, how should...
For manufacturers of electronic medical devices, appointing a WEEE (Waste Electrical and Electronic Equipment) and EPR (Extended Producer Responsibility) representative is a critical step for market a...
With international consensus standards for biocompatibility undergoing periodic updates, how can manufacturers strategically assess the impact of these changes on both new and existing medical devices...