监管知识库

AR roles across MDR, IVDR, GPSR, REACH and DSA, with links into the directory.

What drives AR pricing and how to compare quotes.

Countries and regulations covered by listed Authorized Representatives.

Who must appoint an AR, label requirements, and mandate agreement essentials.

Which regulations require an AR, MDR/IVDR obligations, GPSR expansion, CH-REP vs UKRP.

EU/UK/Swiss coverage, EUDAMED readiness, mandate scope, PRRC separation, insurance.

EU representative requirement for non-EU organisations processing EU personal data.

Legal representative requirement for non-EU digital service providers.

ECHA registration and chemical substance compliance for non-EU businesses.

UKCA, UK MDR, and Great Britain market access requirements.

Swiss data protection representative requirements.

Producer registration and national reporting for electronics and packaging.

General Product Safety Regulation EU Responsible Person requirement.

What separates the two mandatory MDR roles and when you need each.