From FDA Clearance to CE Marking: EU Authorized Representative for United States Manufacturers
FDA runs the largest single-country premarket system in the world, and a US manufacturer arriving at the EU border usually arrives with a thick file and the wrong currency. A 510(k) clearance, a De Novo grant or a PMA approval establishes a US marketing status and nothing more; the EU recognises none of them. What US firms do bring, since QMSR incorporated ISO 13485:2016 into 21 CFR Part 820, is a quality system a notified body will recognise. This page sets out exactly how far that gets you and where the new work starts.
What an FDA decision certifies, and what it leaves blank
The United States runs the largest single-country premarket system for medical devices, and it runs it under its own law. A 510(k) decision answers a comparative question: is this device substantially equivalent to a legally marketed predicate? FDA clears such a device rather than approving it. De Novo answers a classification question for a novel low-to-moderate-risk device with no predicate. A PMA is the only route where FDA approves on the basis of valid scientific evidence that the device is safe and effective for its intended use, and it is reserved for Class III devices.
All three produce a US marketing status. None of them produces a document that has any legal effect in the European Union. There is no mutual recognition of FDA decisions under Regulation (EU) 2017/745. The EU route runs on an EU declaration of conformity that the manufacturer draws up itself under MDR Art. 19, supported by technical documentation to Annexes II and III and, for everything above unqualified class I, a notified body certificate.
Three FDA routes, one European starting line
The useful question is not whether an FDA decision transfers. It does not. The useful question is which of the evidence generated to obtain it can be reused inside an MDR technical file.
| FDA route | What FDA determines | What survives into an MDR file |
|---|---|---|
| 510(k) | Substantial equivalence to a predicate device | Bench testing, biocompatibility, sterilisation and shelf-life data are usually reusable as GSPR evidence. The substantial equivalence determination itself is worth nothing under Annex I. |
| De Novo | Classification of a novel device, with special controls | Risk analysis and the reasoning behind the special controls often map cleanly onto Annex I arguments. The classification does not carry into Annex VIII. |
| PMA | Reasonable assurance of safety and effectiveness for Class III | Clinical investigation data can support the clinical evaluation required by MDR Art. 61 and Annex XIV, provided the data set meets Annex XIV expectations rather than only 21 CFR 814. |
A well-run US file therefore gives a head start on evidence and no head start at all on conformity. The declaration, the classification, the GSPR reasoning and the notified body relationship are new work.
QMSR: the one place where the two systems now genuinely touch
The Quality Management System Regulation amended 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, with a compliance date of 2 February 2026. A US manufacturer operating a QMSR-conformant system is, in substance, operating ISO 13485:2016 plus FDA-specific additions on labelling, records and device history.
That matters under MDR Annex IX, Chapter I. On the notified body's treatment of standards, the Regulation states: "The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiates not doing so." (MDR Annex IX, Section 2.3)
Read that sentence carefully, because the limit is inside it. The presumption runs only as far as the requirements the standard actually covers. MDR Art. 10(9) lists quality system elements that ISO 13485 does not deliver on its own: a strategy for regulatory compliance, identification of the applicable general safety and performance requirements, clinical evaluation under Art. 61 and Annex XIV including PMCF, verification of UDI assignments made under Art. 27(3), a post-market surveillance system under Art. 83, and the vigilance processes of Arts. 87 to 92. QMSR harmonisation closes a large part of the gap. It does not close that part.
Nor does it remove the audit. Annex IX is explicit that the notified body comes to you: "The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes." (MDR Annex IX, Section 2.3)
Where US export portfolios hit MDR friction
US manufacturers reaching the EU tend to cluster in a handful of categories, and each of them meets a specific piece of MDR resistance.
- Clinical decision-support and imaging software. MDR Annex VIII, Rule 11 classifies software that informs diagnostic or therapeutic decisions as class IIa, rising to IIb or III depending on the severity of what a wrong decision could cause. Products handled as FDA Class II frequently land two steps higher in the EU, which converts a self-declared product into a notified body project.
- Reusable surgical instruments. Under MDR Art. 52(7), class I devices that are reusable surgical instruments require notified body involvement, limited to the aspects relating to reuse. US manufacturers used to unrestricted class I self-declaration are often unaware of this.
- Orthopaedic and cardiovascular implants. Class III under Annex VIII, so Annex IX Chapters I and II with a technical documentation assessment, plus a summary of safety and clinical performance under MDR Art. 32.
- In vitro diagnostics. Under IVDR 2017/746 the old self-certification model is largely gone; class B, C and D assays need a notified body, and the performance evaluation expectations are not the same as an FDA analytical and clinical validation package.
- Products in MDR Annex XVI without an intended medical purpose, such as certain aesthetic devices, which are regulated in the EU with no US analogue at all.
Labelling once you leave a single-language market
US instructions for use are written once, in English. MDR Art. 10(11) sets a different expectation: "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (MDR Art. 10(11))
The determination belongs to each Member State, not to the manufacturer, so a distribution plan covering Germany, France, Italy, Spain and Poland is a five-language labelling and IFU obligation before a single unit ships. Annex I, Section 23 also dictates what must appear, which is broader than the US labelling rules and includes UDI carriers, the authorized representative's name and address, and specific warnings.
Running an Article 11 mandate from a US head office
An authorized representative is not a mailing address. The Regulation requires that the mandate oblige the representative to "verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer" (MDR Art. 11(3)(a)). That is a substantive review, and a representative who cannot perform it is not doing the job the law describes.
Medex Kurumsal Danışmanlık is registered in EUDAMED as an authorized representative under SRN TR-AR-000057550, and separately as a manufacturer under TR-MF-000057496 and as an importer. Actor registration in EUDAMED became mandatory on 28 May 2026, together with UDI/device registration, notified bodies and certificates, and market surveillance. The firm keeps its person responsible for regulatory compliance in-house, a partner of the firm, with a deputy, and works from Ankara, İstanbul and Gdańsk. Pricing is published and class-based, with annual fees from EUR 1000; see pricing, the authorized representative service and EUDAMED registration.
Questions US regulatory teams ask first
Does our 510(k) clearance shorten the CE marking process at all?
Not procedurally. It shortens nothing in classification, conformity assessment or the declaration of conformity. It can shorten evidence generation, because the verification and validation data behind the submission is often directly usable against Annex I. Treat the clearance as a source of test reports, not as a credential.
We are QMSR compliant. Do we still need a notified body audit?
Yes, for any device above unqualified class I. QMSR alignment with ISO 13485:2016 means a notified body will find a familiar system and can presume conformity for what the standard covers. It will still audit your premises under Annex IX and will still test the MDR-specific elements that ISO 13485 does not contain.
Can our US entity act as its own authorized representative through a subsidiary?
An authorized representative must be established in the Union and must have accepted a written mandate. An EU subsidiary can hold that role if it is genuinely resourced for it, including permanent access to a person responsible for regulatory compliance. Many US manufacturers find the compliance and liability exposure sits better outside the group.
Our German distributor offered to act as our authorized representative. Is that a problem?
MDR treats manufacturer, authorized representative, importer and distributor as distinct economic operators with distinct obligations, and only one authorized representative may be designated. A distributor whose commercial interest is in volume is being asked to hold a role that includes terminating the mandate if you breach the Regulation. Talk it through with us at contact before signing anything.