MARKETS

Classification is not portable between markets

Six markets classify here today, each under its own rules. A class earned in one jurisdiction says nothing definitive about another. Most markets outside the United States descend from the same GHTF/IMDRF principles and ask recognisably similar questions — which is why one questionnaire can serve many of them — but each reaches its own answer, using its own labels, under its own authority.

Summary

MARKET	APPROACH	CLASSES	STATUS
European Union	Rules cascade	I · IIa · IIb · III	Available
United Kingdom (Great Britain)	Rules cascade	I · IIa · IIb · III	Available
United States	Device catalogue lookup	I · II · III	Catalogue search
Canada	Rules cascade	I · II · III · IV	Available
Australia	Rules cascade	I · IIa · IIb · III · AIMD	Available
Switzerland	Rules cascade	I · IIa · IIb · III	Available
Brazil	Rules cascade	I · II · III · IV	Available
India	Rules cascade	A · B · C · D	Planned
Japan	Device catalogue lookup	I · II · III · IV	Planned
European Union — in vitro diagnostics	Rules cascade	A · B · C · D	Planned

Available today

2.1

European Union

Regulation (EU) 2017/745 (MDR), Annex VIII · CE marking · Rules cascade

Classification follows 22 rules in Annex VIII, applied to the intended purpose rather than the technology. Where several rules apply, the strictest prevails. The class determines the conformity assessment route and whether a Notified Body must be involved.

I LowIIa MediumIIb Medium-highIII High

NOTE —

Notified Body capacity remains a practical constraint; plan lead times for Class IIa and above.

How European Union classifies, in depth Classify a device for this market

2.2

United Kingdom (Great Britain)

UK Medical Devices Regulations 2002, Annex IX (18 rules) · UKCA marking · Rules cascade

Great Britain never adopted the MDR: the rules still derive from Directive 93/42/EEC, so classification runs on the MDD's 18 rules rather than the MDR's 22. The up-classifications the MDR introduced in 2021 simply never happened here — most visibly for software, which has no equivalent of MDR Rule 11 and usually remains Class I.

I LowIIa MediumIIb Medium-highIII High

NOTE —

In flux. The MHRA published a draft amendment in May 2026 introducing a more risk-proportionate, IMDRF-aligned classification framework, expected to be adopted late 2026 and to come into force in 2027. A UK class determined today should be re-checked against the new framework. Northern Ireland follows the EU MDR under the Windsor Framework and is out of scope here.

How United Kingdom (Great Britain) classifies, in depth Classify a device for this market

2.3

United States

21 CFR Parts 862–892 · 510(k), De Novo or PMA · Device catalogue lookup

Structurally different from every other market here. The FDA does not run a rule cascade: it assigns devices to generic device types, each with a classification regulation and a product code that fixes the class and the premarket pathway. Classification therefore means finding the right product code — a search problem, not a decision tree.

I LowII ModerateIII High

NOTE —

Because it is a lookup, no questionnaire can answer it. After classifying under the MDR you can search the FDA product classification catalogue here and select the code yourself; the report then reproduces that entry. Identifying the code is not the whole exercise — a 510(k) also requires a predicate device, and where no generic type fits, the De Novo route applies.

How United States classifies, in depth

Search the product code catalogue

2.4

Canada

Medical Devices Regulations (SOR/98-282), Schedule 1 · Medical Device Licence · Rules cascade

A four-class GHTF-derived cascade that asks recognisably similar questions to Annex VIII. The trap is the labels: Canadian Class III is not EU Class III, and mapping between them by name produces confident wrong answers.

I LowII Low-moderateIII Moderate-highIV High

NOTE —

Duration is a single bright line at 30 days rather than the MDR's three bands, so the European short-term band splits across two Canadian classes. Schedule 1 also has no rule for software: rules 8 to 11 speak of software dedicated to an active device, and standalone software is classified by applying those rules under Health Canada guidance rather than under a provision written for it.

How Canada classifies, in depth Classify a device for this market

2.5

Australia

Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2 · ARTG inclusion · Rules cascade

Closely modelled on the European directives, with an additional distinct category for active implantable devices and its own rules for software, which the TGA has revised in recent years.

I LowIIa Low-mediumIIb Medium-highIII HighAIMD High

NOTE —

The rules encoded here come from Schedule 2 of the Regulations as made, which is the text that could be verified in full; clauses amended since are not reflected. One consequence is deliberate and visible: because the TGA revised the classification of software after that text, no Australian class is offered for software at all. Schedule 2 also has no counterpart to MDR Rules 19 to 22, so nanomaterials, inhalation devices, substance-based devices and closed-loop therapeutic devices are classified on their other characteristics alone.

How Australia classifies, in depth Classify a device for this market

2.6

Switzerland

Medical Devices Ordinance (MedDO / MepV) · CE marking with Swiss authorised representative · Rules cascade

The Swiss ordinance mirrors the MDR classification rules, so the class itself transfers directly. What does not transfer is market access: since mutual recognition lapsed, a Swiss authorised representative and Swiss-specific labelling are required.

I LowIIa MediumIIb Medium-highIII High

NOTE —

The class is produced by the EU engine rather than by a second copy of the same rules, so it cannot drift from the European result. Everything that makes Switzerland a distinct market — authorised representative, labelling, importer obligations — sits outside classification and is not covered here.

How Switzerland classifies, in depth Classify a device for this market

2.7

Brazil

RDC 751/2022 · ANVISA registration or notification · Rules cascade

RDC 751/2022 aligned Brazil much more closely with the international rule set, making it one of the more tractable additions — though registration itself remains documentation-heavy and requires a local holder.

I LowII Medium-lowIII Medium-highIV High

NOTE —

RDC 751/2022 transposes Annex VIII rule for rule, so the reasoning carries across; what does not carry is the label. Brazilian Class III is the equivalent of European Class IIb, and Class IV of European Class III. Two Brazilian provisions have no European counterpart: Regra 16 classifies artificial tears and ophthalmic lubricants as Class III, and Regra 18 states the intact-skin exception without restricting it to material of animal origin.

How Brazil classifies, in depth Classify a device for this market

On the roadmap

Listed with the framework each one actually uses, so you can see what is involved rather than a row of flags. We would rather ship one market that is right than six that are approximately right — nothing below is selectable until its engine has been built and reviewed.

3.1

India

Medical Devices Rules 2017 · Manufacturing or import licence · Rules cascade

A four-class A–D system following GHTF principles. The class determines whether the state or the central authority licenses the device, which in turn changes timelines substantially.

A LowB Low-moderateC Moderate-highD High

How India classifies, in depth

3.2

Japan

Pharmaceuticals and Medical Devices Act (PMD Act) · Shonin / Ninsho / Todokede · Device catalogue lookup

Risk tiers follow GHTF principles, but the class is reached through the JMDN nomenclature — the device is matched to a generic name that carries its classification. Like the US, this is a lookup rather than a cascade.

I GeneralII ControlledIII Highly controlledIV Highly controlled

How Japan classifies, in depth

3.3

European Union — in vitro diagnostics

Regulation (EU) 2017/746 (IVDR), Annex VIII · CE marking · Rules cascade

A separate regulation with an entirely different logic: seven rules that turn on what the test detects and the consequence of a wrong result, not on invasiveness. In vitro diagnostics are out of scope for the MDR engine and need their own.

A Low individual and public health riskB Moderate individual, low public healthC High individual or moderate public healthD High individual and public health

How European Union — in vitro diagnostics classifies, in depth

Common questions

Does an EU MDR class apply in other countries?

No. Each jurisdiction runs its own classification framework and reaches its own class. Many markets derive from shared GHTF/IMDRF principles and often produce a comparable outcome, but the class must be determined separately for each market and the labels are not interchangeable.

Why is US FDA classification different from the EU?

The EU applies a cascade of rules to the characteristics of a device. The FDA instead assigns devices to around 1,700 generic device types, each with its own classification regulation and product code that fixes both the class and the premarket pathway. In the US you look the device up; in the EU you reason it out.

Is Class III the same everywhere?

No, and assuming so is a common and expensive error. In the EU and UK, Class III is the highest risk tier of four. In Canada, Class III is the third of four, with Class IV above it. Comparing classes by label rather than by framework produces confident wrong answers.

A MARKET THAT IS NOT HERE YET

Tell us which markets matter for your device and we will tell you what the route looks like — write to service@mdclassify.com.