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
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.
What EC REP means, who can act as EC REP for a medical device or IVD, and exactly how the EU Authorised Representative must appear on the label under MDR/IVDR Annex I.
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.
UK manufacturers count as non-EU under MDR and IVDR and need an EU Authorised Representative to sell in the EU. Brexit rules, Northern Ireland, and EU AR from €2,700.
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. Before you sign a mandate, we tell you what the next step is.