Regulatory Q&A Forum

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

I have a UK importer handling my devices in the UK. Do I still need a separate UK Responsible Person, or can the importer fulfill both roles?

I'm considering switching UK RPs due to service issues or cost. Can I change my UK Responsible Person, and what's the process? What are the implications for devices already on the market?

I need to update my device labeling for the UK market. What are the specific requirements for indicating the UK RP on labels, packaging, and IFU under UK MDR 2002?

I understand vigilance reporting is required under UK MDR 2002, but I'm unclear on the UK-specific requirements and the UK RP's role in serious incident and FSCA reporting. Can you clarify the process...

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

UK MDR 2002 requires a written mandate between the manufacturer and UK RP. What are the essential elements that must be included to ensure compliance and operational effectiveness?

I'm an EU manufacturer with CE marking under EU MDR/IVDR. I assumed I wouldn't need a UK RP since the UK was part of the EU, but I'm hearing conflicting information post-Brexit. Do EU manufacturers re...

I need to understand the exact scope of UK RP 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 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?