Medical Device Regulatory Assessment: US and EU

What a medical device regulatory assessment is

A medical device regulatory assessment answers four questions before a team commits time and money: Is the product a medical device? What class is it in each target market? Which pathway leads to market? And is the company’s documentation and quality system ready for that pathway? Done early, it shapes design, testing and clinical plans. Done late, it often means rework.

The assessment has become more demanding in 2026. In the US, FDA’s QMSR now requires a quality system that complies with ISO 13485 (eCFR, 21 CFR 820.10). In the EU, EUDAMED registration became mandatory on May 28, 2026 (HPRA), and a proposal to simplify the MDR is moving through the legislative process (European Commission).

The US: classification and premarket pathways

FDA assigns device types “to one of three regulatory classes based on the level of control necessary,” where “Class I includes devices with the lowest risk and Class III includes those with the greatest risk” (FDA). Classification starts by finding the matching classification regulation and product code.

Pathway	When it applies	Basis
Exempt	Many class I and some class II devices	General controls (and special controls for class II)
510(k)	“If your device is classified as Class I or II, and if it is not exempt, a 510k will be required”	Substantial equivalence to a legally marketed predicate
De Novo	Novel low-to-moderate risk devices without a predicate	Classifies the new device type; general or special controls provide assurance
PMA	”For Class III devices, a premarket approval application (PMA) will be required”	Scientific review of safety and effectiveness

Sources: FDA, Classify Your Medical Device; FDA, 510(k); FDA, De Novo; FDA, PMA.

Review timelines matter for planning. Under MDUFA V goals, FDA commits to “a MDUFA decision for 95% of 510(k) submissions within 90 FDA Days” and “within 150 FDA Days for 70% of De Novo requests” (FDA MDUFA V commitment letter). FDA days exclude time waiting for the sponsor’s answers, so real calendar time is usually longer.

The EU: classification and conformity assessment

Under the MDR, “Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks,” following the rules in Annex VIII (MDR Article 51, via Advisera). MDCG 2021-24 rev.1, updated in April 2026, gives classification guidance, and MDCG 2019-11 rev.1 covers software (European Commission MDCG guidance). Most devices above class I need a notified body.

US vs EU at a glance

Topic	United States (FDA)	European Union (MDR)
Risk classes	I, II, III	I, IIa, IIb, III
How class is set	Classification regulations and product codes	Annex VIII rules applied by the manufacturer
Market access	Exemption, 510(k), De Novo or PMA decided by FDA	Conformity assessment, usually by a notified body, then CE marking
Clinical evidence	Depends on pathway; often bench data for 510(k)	Clinical evaluation required for all classes, scaled to risk
QMS	QMSR (ISO 13485 incorporated)	Article 10 QMS, typically ISO 13485-based
Database	FDA registration and listing, GUDID	EUDAMED
Local presence	US agent for foreign firms	EU authorised representative for non-EU firms

The same device can land in different classes. Software and AI-enabled devices are the most common example, so assess each market separately.

How to run a regulatory assessment, step by step

Write the intended use and indications precisely. Everything else depends on this wording.
Confirm device status in each market, including whether software functions qualify as a device.
Classify using FDA product codes and MDR Annex VIII rules, and record the rationale.
Choose the pathway: for the US, search for predicates and weigh 510(k) against De Novo; for the EU, select the conformity assessment route and notified body.
Map evidence needs: bench testing, standards, software, cybersecurity, biocompatibility, usability and clinical data.
Assess QMS readiness against ISO 13485 and QMSR or MDR requirements.
Gap-assess existing documentation against the requirements of the chosen pathways.
Build the plan and timeline, including FDA pre-submission meetings and notified body capacity.
Revisit at design changes and when rules change, such as the MDR simplification proposal.

Regulatory assessment checklist

Turn the assessment into evidence

A regulatory assessment is only as good as the documents behind it. AskDona checks design documents, procedures and draft submissions against FDA, ISO 13485 and EU MDR requirements or your own checklist, flags gaps and inconsistencies, and cites the passage behind every finding.

Run a sample regulatory document assessment on one document. AskDona shows the evidence; your regulatory team decides.

FAQ

What is a medical device regulatory assessment? An evaluation of a product’s device status, classification, market pathway and documentation readiness in each target market.

How do I know if I need a 510(k)? If the device is class I or II and not exempt, FDA requires a 510(k) (FDA).

What if there is no predicate device? The De Novo pathway can classify novel low-to-moderate risk devices (FDA).

Is the FDA class the same as the EU class? Not necessarily; the systems use different classes and rules.

When should a regulatory assessment happen? As early as the intended use is defined, and again whenever design or regulations change.

References

All pages opened and checked by October 13, 2026.

Source	Type	Date	Used for
eCFR: 21 CFR 820	Regulation	Current	QMSR
HPRA: EUDAMED	Competent authority	Mar 23, 2026	EUDAMED date
European Commission: MDR overview	Regulator	2026	Simplification proposal
FDA: Classify your medical device	Regulator	Aug 26, 2026	Classes, pathways
FDA: 510(k)	Regulator	Aug 22, 2024	510(k)
FDA: De Novo	Regulator	Sep 30, 2025	De Novo
FDA: PMA	Regulator	May 16, 2019	PMA
FDA: MDUFA V commitment letter	Regulator	2022	Review goals
Advisera: MDR Article 51	Regulation text reproduction	n.d.	EU classes
European Commission: MDCG guidance	Regulator	2026	Classification guidance