You are in scope, wherever you are
The CRA binds anyone placing a product with digital elements on the EU market. A US startup shipping through Crowd Supply, a UK brand, a Swiss instrument maker, a Taiwanese ODM and their rebadgers are all equally in scope. Where your company is registered does not enter into it.
What is different for you
Three things.
You need an authorised representative in the EU. Someone established in the Union, appointed by written mandate, who keeps the EU declaration of conformity and the technical documentation available to market surveillance authorities and cooperates with them. This is a real appointment with real liability, not a mail-forwarding address.
You cannot use the EU grant funding. The SECURE programme offers up to €30,000 at 50% co-financing for CRA readiness, and cascade funding is scoped to MSMEs established in the EU or associated countries. You are in scope for the obligation and out of scope for the subsidy. Budget accordingly.
Your importer and distributor have obligations too. They must check that you did the conformity assessment, that the CE marking is present and that the technical documentation exists. In practice this means your EU partners will ask you for the file, and a blocked shipment is how most companies find out they do not have one.
What we do about it
USD and GBP pricing, English-first documentation, and a data model that records your authorised representative alongside the manufacturer so the declaration of conformity and the Annex II user information name both correctly. The Article 14 reporting console walks you through EU Login registration, which is not obvious from outside the EU.
We do not act as your authorised representative and we do not sell that service. We tell you what the mandate has to cover so you can appoint one properly.