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...
With the European Chemicals Agency (ECHA) moving towards significant restrictions on per- and polyfluoroalkyl substances (PFAS) under REACH, non-EU manufacturers face a critical compliance challenge. ...
Given the increasing regulatory focus on per- and polyfluoroalkyl substances (PFAS) under REACH, particularly with the development of a universal restriction proposal, how should a non-EU manufacturer...
What factors determine the scope of services and responsibilities for a REACH Only Representative? For non-EU manufacturers of chemical substances, appointing a REACH Only Representative (OR) is a cr...
For a sponsor developing a novel, complex Software as a Medical Device (SaMD) intended for pharmacogenetic assessment, what are the key intersecting regulatory requirements that must be addressed in a...
For non-EU medical device manufacturers, selecting an EU Authorized Representative (AR) under the Medical Device Regulation (MDR) is a critical compliance decision that extends far beyond a simple adm...
When planning for European market entry, non-EU medical device manufacturers often focus on commercial logistics, including the appointment of a VAT Fiscal Representative. However, a distinct and crit...
For medical device manufacturers placing products on the EU market, compliance with the Waste Electrical and Electronic Equipment (WEEE) Directive and national Extended Producer Responsibility (EPR) l...
With significant updates to the EU's Waste Electrical and Electronic Equipment (WEEE) Directive anticipated around 2026, how should medical device manufacturers strategically evaluate and select an EU...
While manufacturers often ask for a single price for a WEEE/EPR Representative in Germany, the cost is not a flat fee but is influenced by several key factors. What are the primary variables that dete...
When a major international standard for the biological evaluation of medical devices is updated, how should manufacturers strategically revise their biocompatibility testing programs for both new and ...
With significant updates to international biocompatibility consensus standards anticipated, how should medical device manufacturers strategically evaluate and select a testing partner to ensure future...
When preparing a 510(k) submission, what does a comprehensive biocompatibility evaluation involve beyond simply selecting tests from a standard? While it is understood that medical devices with direc...
As the UK's post-Brexit medical device regulatory framework continues to evolve towards a new system, non-UK manufacturers face the critical task of ensuring their UK Responsible Person (UKRP) is prep...
For non-UK medical device manufacturers planning for market access, securing a UK Responsible Person (UKRP) is a critical compliance step. As regulatory frameworks evolve, budgeting for this service b...
When non-UK based medical device manufacturers seek to place products on the Great Britain market (England, Wales, and Scotland), they must appoint a UK Responsible Person (UKRP). While the cost of UK...
For sponsors developing a novel pharmacogenetic assessment system, what are the key regulatory hurdles and evidence requirements under 21 CFR 862.3364? This regulation identifies such a device as a qu...