US FDA vs EU MDR, side by side

The US and the EU reach the same goal, safe and effective devices, through different machinery. In the US a single government agency (FDA) reviews and clears or approves devices. In the EU the manufacturer self-declares conformity, and for most devices a private, government-designated notified body audits that claim before the CE mark can be applied.

By Christian Espinosa, Founder, Blue Goat Cyber

Who decides and how

Topic	United States (FDA)	European Union (MDR)	What differs
Legal basis	Federal Food, Drug, and Cosmetic Act and 21 CFR Parts 800 to 89821 CFR Subchapter H	Regulation (EU) 2017/745, directly applicable in every Member StateMDR	Both are binding law. The MDR replaced the earlier directives and applies since 26 May 2021.
Who grants market access	FDA (CDRH) clears, grants or approves the deviceFD&C Act sections 510(k), 513(f)(2), 515	Manufacturer declares conformity; a notified body certifies most devicesMDR Articles 52 and 53	In the US the regulator reviews the file. In the EU a designated private body audits it, and national competent authorities supervise the market.
Evidence of market access	510(k) clearance letter, De Novo grant or PMA approvalFDA databases	CE marking backed by an EU declaration of conformityMDR Articles 19 and 20	A CE mark is valid across the EU and EEA; an FDA decision covers the US only.

Classification and pathways

Topic	United States (FDA)	European Union (MDR)	What differs
Risk classes	Class I, II, III, set by product classification regulations21 CFR Parts 862 to 892	Class I, IIa, IIb, III, set by 22 rulesMDR Annex VIII	US classes come from a lookup by device type; EU classes come from applying rules (invasiveness, duration, active or not). The same device can land in different classes.
Moderate-risk route	510(k), showing substantial equivalence to a predicate21 CFR Part 807 Subpart E	Conformity assessment with notified body (Class IIa and IIb)MDR Article 52, Annexes IX to XI	The EU has no predicate concept. Equivalence can support clinical evaluation, but the device must meet the GSPRs on its own evidence.
Novel low or moderate risk	De Novo classification requestFD&C Act section 513(f)(2)	No separate pathway; classify by Annex VIII rulesMDR Annex VIII	De Novo creates a new classification regulation that later devices can use as a predicate.
Highest risk	Premarket approval (PMA)21 CFR Part 814	Class III notified body assessment, with expert panel consultation for some implantablesMDR Article 54	Both require clinical data. PMA approval is device-specific and changes need PMA supplements.
Early regulator feedback	Q-Submission (Pre-Sub)FDA Q-Submission program	Structured dialogue with the notified body; expert panel adviceMDR Article 61(2), Article 106	Notified bodies may not provide consultancy, so EU early dialogue is narrower than an FDA Pre-Sub.

Quality and technical documentation

Topic	United States (FDA)	European Union (MDR)	What differs
Quality management system	QMSR, which incorporates ISO 13485:2016 by reference (effective 2 February 2026)21 CFR Part 820	QMS required by MDR, usually demonstrated through ISO 13485MDR Article 10(9)	With QMSR, the US and EU now share the same core QMS standard, though each adds its own requirements.
Design and risk	Design controls and risk management21 CFR Part 820, ISO 13485 clause 7.3	GSPRs plus risk management, usually via ISO 14971MDR Annex I	ISO 14971 is recognized by FDA and harmonised in the EU, so one risk file can serve both.
Technical file	Submission content (510(k), De Novo, PMA) plus the design history21 CFR 807.87, 814.20	Technical documentation per Annexes II and IIIMDR Annexes II and III	The EU file is a standing, maintained document; the US file is mainly what is submitted for each decision.
Responsible person	No equivalent single named role-	Person responsible for regulatory compliance (PRRC)MDR Article 15	Non-EU manufacturers also need an EU authorised representative (MDR Article 11).

Clinical evidence

Topic	United States (FDA)	European Union (MDR)	What differs
Clinical studies	Investigational Device Exemption (IDE) for significant-risk studies21 CFR Part 812	Clinical investigations authorised by Member StatesMDR Articles 62 to 82, ISO 14155	Both follow ISO 14155 and good clinical practice principles.
Ongoing clinical evaluation	No standing requirement for most cleared devices-	Clinical evaluation updated with post-market clinical follow-upMDR Article 61, Annex XIV	The EU expects clinical evidence to be updated for the life of the device.
Public summary	510(k) summary, De Novo decision summary, PMA SSEDFDA databases	Summary of safety and clinical performance (Class III and implantables)MDR Article 32	The SSCP is published through EUDAMED.

Identification and post-market

Topic	United States (FDA)	European Union (MDR)	What differs
Unique device identification	UDI with data in GUDID21 CFR Part 830	UDI with data in EUDAMED, plus Basic UDI-DIMDR Article 27	Both use the same issuing agencies (for example GS1), but data elements differ.
Adverse event reporting	Medical Device Reporting (MDR) to FDA21 CFR Part 803	Vigilance reporting of serious incidentsMDR Articles 87 to 92	Watch the acronym clash: in US usage MDR means Medical Device Reporting.
Field actions	Recalls and corrections and removals21 CFR Parts 7 and 806	Field safety corrective actions (FSCA)MDR Article 89	Both require notifying the regulator and affected users.
Periodic safety reporting	PMA annual reports; no general periodic report for 510(k) devices21 CFR 814.84	PSUR (Class IIa and above) or PMS report (Class I)MDR Articles 85 and 86	The EU requires periodic summaries for most device classes.

Primary sources

Educational summary, not legal advice. Always check the current text of the law and guidance.