What EU MDR requires that FDA doesn’t

Someone who has only ever worked FDA submissions tends to picture the EU as a lighter version of the same process — a different form, a different acronym, roughly the same idea. It isn’t. The EU Medical Device Regulation, Regulation (EU) 2017/745, builds its whole structure around a different actor doing the reviewing and a different relationship to evidence over time. Neither of those differences is cosmetic, and both show up the first time someone tries to map a 510(k) plan directly onto a CE-marking plan.

Nobody at an agency reviews the file

A 510(k) or PMA is reviewed by FDA staff, and the clearance or approval that comes back is a decision by a public authority. The MDR doesn’t work that way for most devices. Class IIa, IIb, and III devices go through conformity assessment performed by a Notified Body — a private organization accredited by an EU member state to assess manufacturers against the regulation. A CE certificate is that Notified Body’s attestation of conformity, not a government approval, and the distinction matters in practice: manufacturers choose which accredited Notified Body to work with, timelines and costs vary between them, and there is no single public queue the way there is for FDA review. The regulation compensates for that lack of a single institutional reviewer with an accountability requirement FDA doesn’t impose in the same form: under Article 15, manufacturers must have at least one named Person Responsible for Regulatory Compliance within the organization, meeting minimum qualifications the regulation itself spells out — generally a relevant degree plus a year of hands-on regulatory experience, or several years of direct experience in lieu of the degree. FDA doesn’t require a company to name an individual this way. The MDR does, precisely because the reviewing body isn’t a public agency answerable to anyone but its own accreditation.

The clinical evidence obligation doesn’t stop at the certificate

A 510(k) built on a strong predicate can clear with comparatively little new clinical data, and once cleared, the ongoing federal obligation is narrower — complaint handling, adverse event reporting, and postmarket surveillance orders where FDA specifically requires one under Section 522. The MDR treats the period after certification as an active phase of evidence-gathering, not a finish line. Post-Market Clinical Follow-up, detailed in Annex XIV Part B, requires manufacturers to proactively and continuously collect clinical data on a device already on the market, feeding into a Periodic Safety Update Report for higher-risk classes or a Post-Market Surveillance Report for Class I, updated on a defined schedule for as long as the device is sold. The Clinical Evaluation Report itself is meant to be a living document, revisited against the current state of the art rather than written once and filed away. None of this is a claim that the EU pathway is harder or easier than the FDA one across the board — the two systems are structured around different tradeoffs, and comparing total burden requires comparing a specific device against both frameworks, not a general vibe. What’s reliably true is that the MDR’s clock doesn’t stop at the certificate the way a submission-focused mental model expects it to.

The two systems do share more plumbing than people expect once you get past the top-level differences — both lean on ISO 13485-based quality management, for instance, which is part of why the QMSR’s move toward the same standard matters beyond FDA’s own borders. But the review relationship itself has no real FDA analog worth forcing: there’s no ongoing reviewer conversation with a Notified Body the way there can be with an FDA lead reviewer during an active submission, and treating the two as interchangeable is where a lot of otherwise solid regulatory judgment goes sideways on a first EU project.