FDA clearance does not equal EU MDR compliance. This hub maps the real gaps between US and European requirements — and how Stockholm-based NordMDR AB helps US manufacturers enter Europe without regulatory surprises.
If you are a US medtech company with FDA 510(k) clearance and a European distributor asking for CE marking, you are not alone. Most US traffic to NordMDR comes from manufacturers who assumed FDA data would transfer directly to the EU. It does not — but much of your existing evidence can be reused with the right structure.
US regulatory managers often compare a 510(k) clearance to EU MDR Class IIa certification. The risk profiles overlap, but the evidence packages are built on different legal frameworks.
| Requirement area | FDA 510(k) (US) | EU MDR Class IIa |
|---|---|---|
| Legal basis | FD&C Act — substantial equivalence | EU MDR 2017/745 — conformity assessment |
| Clinical evidence | Predicate comparison often sufficient | Clinical evaluation per MDR Annex XIV — literature + data |
| Technical documentation | 510(k) summary + design controls | Annex II/III technical file — GSPR checklist mandatory |
| Post-market | MDR reporting, recalls | PMCF plan, PSUR, vigilance to EU AR |
| EU economic operator | Not required | EU Authorised Representative mandatory (Article 11) |
| Database registration | FDA establishment registration | EUDAMED actor + device registration (SRN) |
| Conformity assessment | Self-submission to FDA | Notified Body audit required for Class IIa |
The most common failure mode: submitting a 510(k) dossier to a Notified Body and expecting acceptance. NBs require MDR-structured documentation regardless of your FDA status. Start with a formal EU MDR gap assessment before engaging a Notified Body.
Your FDA evidence is a starting point — not a shortcut. Here is what typically transfers and what must be created new:
NordMDR’s EU MDR consulting team maps your existing FDA dossier against Annex II/III requirements and delivers a written gap report with fixed-fee remediation options — typically within 5 business days.
Audit your FDA documentation against EU MDR Annex II/III. Written report with prioritised actions.
Step 2Mandatory for all non-EU manufacturers. Stockholm-based, EU-wide coverage under one agreement.
Step 3Actor SRN and device registration — mandatory since 28 May 2026.
Step 4Class III by Dec 2027, Class IIa by Dec 2028. Check your device class dates now.
Selling in Switzerland too? The EU Rep does not cover Switzerland — you need a separate Swiss CH-REP under MedDO.
Tell us your FDA clearance status and target EU device class. Our Stockholm team responds within 2 hours with a practical pathway — no obligation.
Book a Free US-to-EU Compliance Review →Also see: FAQ for US manufacturers · UKCA vs CE marking · Free compliance checklist (PDF)