GUIDE

Medical device classification: FDA, TGA and EU MDR compared

Classification decides how much regulatory work a device needs, which conformity assessment or premarket route applies, and what evidence is likely to be expected. The three frameworks below use similar language and different rules. This page is a plain-language orientation, not a classification determination.

PUBLIC SOURCES · PLAIN-LANGUAGE ORIENTATION · NOT A CLASSIFICATION DETERMINATION

United States (FDA)

Class I, Class II, Class III

HOW CLASS IS DETERMINED: Classification follows the device's regulation and product code in 21 CFR Parts 862-892, which group devices by panel and intended use rather than by a general set of rules. Risk-based controls increase with class.
ROUTE TO MARKET: Most Class I devices are exempt from premarket review. Class II typically proceeds through a 510(k) premarket notification against a legally marketed predicate device, or through De Novo where no predicate exists. Class III generally requires premarket approval (PMA).
WORTH NOTING: Predicate and substantial-equivalence terminology is specific to the United States and does not carry across to other jurisdictions.

FDA: Classify your medical device

Australia (TGA)

Class I, Class I measuring / sterile, Class IIa, Class IIb, Class III, AIMD

HOW CLASS IS DETERMINED: Classification is rule-based. The classification rules in the Therapeutic Goods (Medical Devices) Regulations 2002 are applied to the device's intended purpose, degree of invasiveness, duration of contact and, for software, the significance of the information it provides.
ROUTE TO MARKET: The manufacturer applies conformity assessment procedures appropriate to the class, then the sponsor applies to include the device in the Australian Register of Therapeutic Goods (ARTG). Higher classes attract greater TGA assessment involvement.
WORTH NOTING: Programmed or programmable medical devices, including software, are subject to specific classification rules that changed in recent years.

TGA: Medical device classification

European Union (EU MDR)

Class I, Class Is / Im / Ir, Class IIa, Class IIb, Class III

HOW CLASS IS DETERMINED: Annex VIII of Regulation (EU) 2017/745 sets out the classification rules, applied to intended purpose, duration of use, invasiveness, whether the device is active, and specific rules for software and substance-based devices.
ROUTE TO MARKET: The class determines the conformity assessment route under Annexes IX-XI and the extent of notified body involvement. Class I devices other than sterile, measuring or reusable surgical instruments can be self-declared.
WORTH NOTING: Classification under the EU MDR can differ from the classification the same device held under the earlier Medical Devices Directive.

Regulation (EU) 2017/745, Annex VIII

Where teams are most often caught out

01Class names look comparable but are not equivalent. A Class II device in the United States is not automatically Class IIa in the European Union or Australia.
02The United States classifies primarily by existing device regulation and product code; Australia and the European Union apply general rules to the stated intended purpose.
03Software and AI-enabled functions are classified through specific rules, and small differences in the intended purpose or the clinical significance of the output can move the class.
04Intended-use and indications wording is often the decisive input. Wording written for marketing can imply a different class from wording written for regulatory purposes.
05Classification drives evidence expectations. Deciding it late usually means evidence planning has already been built on an assumption.

Working out which class and pathway your device is likely to fall into

Falcr completes an independent regulatory pathway review from a short, non-confidential device description, intended use, classification-relevant characteristics and target jurisdictions. You receive a source-linked, human-reviewed Regulatory Pathway Brief covering the likely classification and pathway, relevant public regulatory predicates, evidence expectations and what still requires formal confirmation.

Book a 20-minute second-opinion fit check See what the brief covers

Nothing on this page is a classification determination, regulatory advice or legal advice. Classification for a specific device depends on its full intended purpose and characteristics, and remains the manufacturer's responsibility to determine and, where required, confirm with the relevant authority or notified body.