A 510(k) clearance, a quality system audited against QMSR and a GUDID listing do not transfer to the European Union. Parts of the same evidence base do. This page separates the two, requirement by requirement, and shows which steps a company without an EU address cannot legally complete on its own.
The table reflects a first review of files we receive from US manufacturers. It is a starting point for scoping, not a conformity assessment.
| Element | Status in the EU file | What is usually missing |
|---|---|---|
| Quality management system | Reusable in substance | MDR-specific processes: PRRC, PSUR, PMCF, vigilance timelines, UDI assignment |
| Design history file | Reusable as input | Technical documentation structured to Annex II and III, with a GSPR list against Annex I |
| Bench and performance testing | Mostly reusable | Testing to the EU harmonised versions of the standards, national deviations for electrical safety |
| Biocompatibility | Mostly reusable | Chemical characterisation and toxicological risk assessment at the depth notified bodies ask for |
| Sterilization and packaging | Partly reusable | Sterility assurance level for the STERILE claim, residual limits, packaging validation and shelf life |
| Clinical evidence | Rarely reusable as filed | A clinical evaluation under Article 61, not a predicate comparison |
| Labelling and instructions | Not reusable | Symbols, UDI carrier, languages of each Member State of sale, importer and representative details |
| Device listing | Not reusable | Basic UDI-DI and UDI-DI in EUDAMED, which is a different data model from GUDID |
| Legal presence | Does not exist in the US system | A mandated authorised representative established in the Union |
The FDA reviews most devices before they reach the market and issues a decision on that specific device. The European system works the other way round. The manufacturer declares conformity, a notified body certifies the quality system and the technical documentation where the class requires it, and market surveillance authorities intervene afterwards.
That difference has a practical consequence for a company in the United States. The European file is not a submission that closes once it is accepted. It has to stay current, it has to be produced on request in a Union language, and there has to be somebody inside the EU who can produce it. That is the role Article 11 MDR assigns to the authorised representative.
Each answer is a separate briefing with the underlying articles and standards.
Which modules became mandatory in May 2026, which devices the twelve-month registration obligation actually covers, and why a US manufacturer cannot obtain a single registration number alone.
Read the EUDAMED briefing →The FDA now incorporates ISO 13485:2016 by reference. The gap towards MDR conformity is smaller than it was and still substantial.
Read the quality system comparison →Sterility assurance level for the STERILE claim, ethylene oxide residuals, packaging validation, shelf life, and why a sterile class I device still needs a notified body.
Read the sterilization briefing →The Cyber Resilience Act does not apply to your device. It can apply to the portal, the companion software without a medical purpose and the tools you ship around it.
Read the cybersecurity briefing →Article 10a MDR requires advance notice of an interruption or discontinuation of supply, addressed to the authority where your authorised representative is established.
Read the supply obligation briefing →A predicate is not an equivalent device. What can be carried across from the submission, and what has to be generated before a notified body will look at the file.
Read the clinical evidence briefing →Article 11(3) MDR lists the tasks the mandate must cover. None of them can be performed from an address outside the EU.
Verify that the EU declaration of conformity and the technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure.
Comply with its own registration obligations under Article 31 and verify that the manufacturer has complied with the registration obligations in Articles 27 and 29.
Keep a copy of the technical documentation, the declaration of conformity and any certificate available for competent authorities.
Provide an authority, in the language that authority determines, with all information and documentation needed to demonstrate conformity.
Forward requests for samples or access to the device to the manufacturer and confirm that the authority received them.
Cooperate on any preventive or corrective action taken to eliminate or mitigate risk posed by devices.
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users concerning suspected incidents related to the devices covered.
Terminate the mandate if the manufacturer acts contrary to its obligations, and inform the competent authority and, where applicable, the notified body of the termination and its reasons.
It shortens the work, not the procedure. Test reports, risk management and much of the design evidence are reusable. The conformity assessment itself, the clinical evaluation and the registration obligations start from the European rules.
Only if that is what the mandate says and the company accepts the tasks in Article 11(3). A distributor and an authorised representative are separate economic operators with separate obligations, and combining them in one company creates a conflict a manufacturer should think through before signing.
Yes. Registration, the representative and the technical documentation are Union obligations. Language requirements, on the other hand, follow the Member States where the device is made available.
That depends on the body, the class and the completeness of the file. We do not quote a certification timeline before seeing the documentation, and we would treat any fixed promise made before that review with caution.
The first review connects the US evidence already held, the proposed EU classification, the conformity-assessment route and the authorised representative mandate.
The MDR, the modular EUDAMED roll-out Regulation and the Commission EUDAMED overview were checked for the obligations described on this page.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · Regulation (EU) 2024/1860 in EUR-Lex → · European Commission: EUDAMED overview →