Changing your EU Authorised Representative
How to switch EU Authorised Representative under Article 12 MDR/IVDR: the tripartite agreement, what it must cover, labelling transition, EUDAMED and document transfer.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Practical guides for medical device and IVD manufacturers established outside the EU, under MDR (EU) 2017/745 and IVDR (EU) 2017/746.
How to switch EU Authorised Representative under Article 12 MDR/IVDR: the tripartite agreement, what it must cover, labelling transition, EUDAMED and document transfer.
What the written mandate between a non-EU manufacturer and its EU Authorised Representative must cover under Article 11 MDR/IVDR, what cannot be delegated, and the AR's joint liability for defective devices.
Where and how the EU Authorised Representative's name and address must appear on medical device and IVD labels under MDR/IVDR Annex I, the EC REP symbol, and importer details.
How economic operator registration in EUDAMED works for non-EU manufacturers and their EU Authorised Representatives: the Single Registration Number, the AR's verification role and data updates.
Serious incident reporting deadlines under Article 87 MDR / Article 82 IVDR, field safety corrective actions, and what the EU Authorised Representative does in vigilance for a non-EU manufacturer.
What Chinese medical device and IVD manufacturers need to place devices on the EU market: an EU Authorised Representative, CE marking under MDR/IVDR, EU labelling, EUDAMED and vigilance.
What US medical device and IVD manufacturers need for the EU market: why FDA clearance does not replace CE marking, how the EU Authorised Representative differs from the FDA US Agent, and what to prepare.
What UK medical device and IVD manufacturers need to sell in the EU after Brexit, how Northern Ireland is treated under the Windsor Framework, and how the EU AR differs from the UK Responsible Person.
Why Swiss medical device and IVD manufacturers have needed an EU Authorised Representative since the EU-Switzerland MRA was not updated for the MDR, and what to prepare.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.