A practical review route for consumer-facing medical-device claims, packaging statements, sustainability labels and climate-offset messaging before the new EU rules apply.
Green Claims on Medical Devices: What Manufacturers Must Change by 27 September 2026 Read More »
The legal, technical, quality and post-market warning signs that should stop an EC REP from accepting—or require it to terminate—a mandate.
When Should an EU Representative Decline a Mandate? Read More »
An EC REP mandate continues after registration: controlled records, authority requests, complaints, vigilance, corrective actions and portfolio changes all require active coordination.
What Does Ongoing EU Representation Actually Involve? Read More »
A reliable MDR or IVDR quotation starts with the intended purpose, classification rationale and conformity-assessment route—not a product name alone.
Why Classification Should Be Checked Before You Request a Quote Read More »
The conformity, representation, registration, labelling and supply-chain records that should be controlled before an EU importer starts placing devices on the market.
What Must Be Ready Before the First EU Importer Is Appointed? Read More »
FDA, Health Canada, Swissmedic and other home-market records can support an EU file, but they do not transfer automatically into MDR or IVDR conformity.
Can Non-EU Regulatory Records Be Reused in the EU? Read More »
A decision guide for non-EU medical-device and IVD manufacturers: when an EC REP is required, what must be checked and when the mandate should begin.
Do I Need an EU Authorized Representative? Read More »