Regulatory Q&A Forum

I'm ready to engage an EU AR provider but want to make sure I'm comparing providers effectively. What should I evaluate when comparing EU AR providers, and what questions should I ask?

I have an EU importer handling my devices in the EU. Do I still need a separate EU Authorized Representative, or can the importer fulfill both roles?

I'm considering switching EU ARs due to service issues or cost. Can I change my EU Authorized Representative, and what's the process? What are the implications for devices already on the market?

I need to update my device labeling for the EU market. What are the specific requirements for indicating the EU AR on labels, packaging, and IFU under MDR/IVDR?

I understand vigilance reporting is required under MDR/IVDR, but I'm unclear on the EU-specific requirements and the EU AR's role in serious incident and FSCA reporting. Can you clarify the process?

I'm unclear about technical documentation requirements for EU AR. Does the EU AR need to physically hold the technical file, or can the manufacturer provide it directly? What are the timelines and obl...

EU MDR/IVDR requires a written mandate between the manufacturer and EU AR. What are the essential elements that must be included to ensure compliance and operational effectiveness?

I have an EU importer/distributor and I'm wondering if they can also serve as my EU AR to simplify things. Is this allowed under EU MDR/IVDR, and what are the implications?

I need to understand the exact scope of EU AR responsibilities. What are they legally required to do versus what they might offer as additional services? Also, what are common misconceptions about the...

I'm assembling procedure packs for the Swiss market and I'm confused about CH-REP requirements. Does each individual device component need its own Swiss Authorized Representative, or can one CH-REP co...

I'm ready to engage a CH-REP provider but want to ensure I provide all necessary information upfront to get accurate quotes and avoid delays. What should I prepare?

I'm trying to understand the distinction between CH-REP, importer, and distributor roles in Switzerland. Can a single company fulfill multiple roles, and what are the implications?

I understand vigilance reporting is required, but I'm unclear on the Swiss-specific requirements and the CH-REP's role in serious incident and FSCA reporting. Can you clarify the process?

I'm confused about technical documentation requirements for CH-REP. Does the CH-REP need to physically hold the technical file, or can the manufacturer provide it directly? What are the timelines?

I need to update my device labeling for the Swiss market. What are the specific requirements for indicating the CH-REP on labels, packaging, and IFU? Can I use the symbol or must I use text?

I keep hearing about CHRN (Swiss Single Registration Number) but I'm unclear on who needs it, the timeline, and costs involved. Can you break down the CHRN registration process?

Swissmedic requires a written mandate between the manufacturer and CH-REP. What are the essential elements that must be included to ensure compliance and operational effectiveness?

I need to understand the exact scope of CH-REP responsibilities. What are they legally required to do versus what they might offer as additional services? Also, what are common misconceptions about th...

I'm an EU manufacturer with CE marking under MDR/IVDR. I assumed I wouldn't need a CH-REP since Switzerland is similar to the EU, but I'm hearing conflicting information. Do EU manufacturers really ne...

For manufacturers of medical devices, including Class I products exempt from premarket notification, compliance with FDA's General Controls is a fundamental requirement. While concepts like Establishm...