How do US manufacturers with FDA clearance achieve EU market access?
An FDA clearance carries no legal weight in the EU, because MDR and IVDR assess the device again against their own evidence rules. EU market access then rests on three obligations without a US counterpart: an authorised representative, EU-format technical documentation and EUDAMED registration.
Overview
What changes when an FDA-cleared device is taken to Europe?
Regulatory teams in Munich, Basel, Milan and Boston · MDR, IVDR, EUDAMED and FDA QMSR handled by one project team
Last updated: September 13, 2026
The FDA and the EU ask different questions about the same device. The FDA asks whether a device is substantially equivalent to one already on the market, while MDR and IVDR ask whether the clinical evidence held for this specific device carries every claim made for it.
- Substantial Equivalence does not transfer. A 510(k) under 21 CFR Part 807 argues from a predicate device, whereas MDR Art. 61 and Annex XIV require a clinical evaluation of the device itself, with a literature appraisal and a benefit-risk analysis against the state of the art. That appraisal is rarely part of a US submission, so the gap becomes visible only in the notified body review.
- Three obligations have no counterpart in the US system. An authorised representative established in the Union under MDR Art. 11 or IVDR Art. 11 carries legal duties toward the authorities, registration in EUDAMED produces the SRN and the UDI records, and the technical documentation follows MDR Annex II and III rather than the FDA submission structure.
- The quality system is closer than it used to be, without being equivalent. Since 2 February 2026 the QMSR (21 CFR Part 820) references ISO 13485:2016, so a manufacturer that holds up under an FDA inspection already operates much of what a notified body examines under MDR Annex IX. Missing from the QMSR are the MDR-specific parts, from post-market clinical follow-up to the person responsible for regulatory compliance under Art. 15.
- Notified body capacity sets the calendar, not the internal project plan. Team-NB reports typical MDR and IVDR review times of 13 to 18 months, and an incomplete first submission adds a full question round to that.
Services
How we support you
Gap Analysis of the FDA File Against MDR
Review of the existing 510(k), De Novo or PMA documentation against MDR Annex II and III and the clinical evidence requirements of Art. 61, delivered as a written gap list that separates what can be reused from what has to be generated.
Authorised Representative & Economic Operators
Setup of the mandate under MDR Art. 11 or IVDR Art. 11, including the written mandate itself, the division of duties with importers and distributors, and the appointment of the person responsible for regulatory compliance under Art. 15.
How we work together
What it comes down to
FDA clearance and CE marking answer two different questions.
A 510(k) under 21 CFR Part 807 establishes that a device is substantially equivalent to a predicate already on the US market. MDR Art. 61 asks something else entirely: whether the clinical data held for this device supports every claim made for it, measured against the current state of the art.
The predicate comparison that carries a US submission is therefore not an EU clinical evaluation. It is the starting point for one.
Three obligations have no counterpart in the US system, and each carries a lead time that launch plans routinely underestimate.
The authorised representative under MDR Art. 11 has to be established in the Union and takes on duties that are checked: verifying the declaration of conformity, keeping the technical documentation available for the authorities, and cooperating on preventive and corrective action. A representative who signs a mandate without ever seeing the file will hand it back when an authority asks for something.
EUDAMED is no longer optional. The first four modules have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371, and the actor registration produces the SRN that a notified body application asks for. Legacy devices follow by 28 November 2026, certificates issued before the module became mandatory by 28 May 2027.
The technical documentation follows MDR Annex II and III. An FDA file holds most of the underlying engineering evidence but organizes it differently, and the parts the EU requires without a US equivalent, namely the GSPR checklist, the post-market surveillance plan and the PMCF plan, are usually absent.
One thing has moved in the US manufacturer's favor. Since 2 February 2026 the QMSR (21 CFR Part 820) references ISO 13485:2016, so a company that holds up under an FDA inspection already operates most of what a notified body examines in an Annex IX audit. The remaining distance is MDR-specific rather than structural, covering post-market clinical follow-up, the vigilance reporting thresholds and the person responsible for regulatory compliance under Art. 15.
What sets the calendar is neither the file nor the quality system. Team-NB reports review times of 13 to 18 months for MDR and IVDR, and an incomplete first submission adds a full question round on top of that.
In the EU entry projects Entourage runs for US manufacturers, the schedule slips in the clinical evaluation and in the EUDAMED data reconciliation, not in the correspondence with the notified body.
| Obligation | Legal basis | Nearest US counterpart |
|---|---|---|
| Authorised representative | MDR Art. 11 / IVDR Art. 11 | US Agent (21 CFR Part 807) |
| Technical documentation | MDR Annex II and III | 510(k) or PMA submission |
| Database registration | MDR Art. 33 / IVDR Art. 30 | FDA Establishment Registration |
| Quality system audit | MDR Annex IX | QMSR inspection (21 CFR Part 820) |
| Regulatory compliance officer | MDR Art. 15 | no direct equivalent |
Our approach
Our approach
Step
Result
FDA File Review
An inventory of the existing submission showing which evidence is reusable for MDR or IVDR and which is US-specific.
Route & Gap List
Classification under MDR Annex VIII or IVDR Annex VIII, the conformity assessment route, and a prioritized gap list with effort and lead times.
Representation & Registration
A signed authorised representative mandate, an appointed person responsible for regulatory compliance and actor registration in EUDAMED with the SRN issued.
Documentation Build
Technical documentation to MDR Annex II and III, including the clinical evaluation report and the post-market surveillance and PMCF plans.
Notified Body Submission
A filed application with a selected notified body and a schedule for the Annex IX audit and the technical documentation assessment.
Certificate & Market Entry
The EU certificate, the declaration of conformity, device registration in EUDAMED and a running post-market surveillance cycle.
Common pitfalls
Where projects commonly fail
The 510(k) is submitted as the clinical evidence.
Substantial Equivalence to a predicate is a US construct, while MDR Art. 61 asks whether the clinical data covers this device and its claims against the state of the art. A notified body that receives the predicate comparison in place of a clinical evaluation returns it as a major non-conformity.
The authorised representative is treated as a mailbox.
Under MDR Art. 11 the representative verifies the declaration of conformity, keeps a copy of the technical documentation available for the authorities and may terminate the mandate. A provider selected on annual fee alone hands the file back when it turns out to be incomplete, and the mandate ends before the submission does.
EUDAMED is postponed until after certification.
Actor registration produces the SRN that a notified body application already asks for, so a company that registers late waits for a number it could have held months earlier.
The QMSR inspection is counted as the MDR audit.
Since 2 February 2026 the QMSR references ISO 13485:2016, which does narrow the gap, but an MDR Annex IX audit additionally examines the post-market surveillance system, the PMCF plan and the person responsible for regulatory compliance under Art. 15.
US labeling is translated instead of rebuilt.
MDR Annex I Chapter III sets its own content requirements for the instructions for use, and the member states decide which languages are required. A translated FDA label is missing required content before the language question even arises.
The launch date is derived from the submission date.
With review times of 13 to 18 months and a question round on an incomplete file, a commercial plan that assumes certification one quarter after filing will slip.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): Art. 11, 15, 33, 61, Annex I, II, III, IX and XIV
- Regulation (EU) 2017/746 (IVDR): Art. 11 and Art. 30
- European Commission: the first four EUDAMED modules are mandatory from 28 May 2026: https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
- Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860 (phased EUDAMED rollout; legacy devices by 28 November 2026, earlier certificates by 28 May 2027)
- FDA, Quality Management System Regulation (QMSR), in force since 2 February 2026, 21 CFR Part 820 referencing ISO 13485:2016: https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
- 21 CFR Part 807 (Establishment Registration, US Agent and 510(k) premarket notification)
- RAPS, reporting Team-NB's 2025 notified body survey: typical MDR and IVDR review times of 13 to 18 months: https://www.raps.org/resource/team-nb-survey-shows-slowdown-in-growth-of-mdr-and-ivdr-certificates-issued-in-2025.html
- GVP Module I (pharmacovigilance systems and their quality systems)
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Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Art. 11 (authorised representative)
- MDR Art. 15 (person responsible for regulatory compliance)
- MDR Art. 61 and Annex XIV (clinical evaluation)
- MDR Annex II and III (technical documentation)
- MDR Annex IX (quality system and technical documentation assessment)
- EU 2017/746 (IVDR), Art. 11 and Art. 30
- MDR Art. 33 (EUDAMED)
- Commission Decision (EU) 2025/2371 (functionality of the first four EUDAMED modules)
- Regulation (EU) 2024/1860 (phased EUDAMED rollout)
- 21 CFR Part 820 (Quality Management System Regulation, QMSR)
- 21 CFR Part 807 (Establishment Registration and 510(k))
- ISO 13485:2016 (QM system)
- ISO 14971 (risk management)
- GVP Module I (pharmacovigilance systems)
Related topics
QPPV Services →
EU-resident QPPV and PSMF under GVP Module I for medicinal products
Inspection Readiness →
Mock inspections and on-site support for FDA, EMA and notified bodies
IVD Consulting & IVDR Readiness →
Classification, performance evaluation and Annex IX for IVD portfolios
EUDAMED →
Actor registration, SRN and UDI across the four mandatory modules
International Market Access →
The opposite direction: EU manufacturers entering the USA, APAC and LATAM
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