Free Medical Device Classification Tool: Compare Risk Class Across Markets

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AI Device Classifiers

Check a medical device risk class across 41 markets, with explanations and source links

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Use one product context, not one vague product name

A classification tool is most useful when it receives the facts that drive classification. “Ultrasound device” or “catheter” is usually not enough. Intended purpose, patient population, anatomy, duration of contact, invasiveness, active function, measuring function, sterility, software behavior, and therapeutic or diagnostic role can change the result.

Open the Classification tool above, choose the market, and describe the actual product. If an important fact is unknown, say that it is unknown rather than supplying a typical answer.

Build reusable input with Product Profile Builder

When you are comparing several markets, start with Product Profile Builder. It turns the available product material into reusable structured context so each classifier sees the same intended purpose and technical facts. This prevents one country result from being based on a different description of the product.

The profile is not a classification conclusion. It is the shared input. Country-specific rules should still produce country-specific answers.

What a useful classification result should show

If two markets produce different classes, the tool should explain the differing rules or triggers. A global normalized label is useful for comparing results, but it should not overwrite the official local class.

Check comparable public records

Use Device Registrations to search for products with similar intended use and technology in the selected market. Comparable registrations can reveal local terminology and show how the authority publishes class information. They are evidence to inspect, not an automatic classification shortcut.

Compare the characteristics that drive the rule. A registration with a similar product name may use a different duration, anatomy, mode of action, or intended purpose.

Separate classification from certification applicability

Classification estimates risk class under a market's device rules. Certification Applicability asks a different question: whether a product may require a particular certification or conformity route. Use the Certification Applicability Checker when that is the task. Keeping the tools separate makes the input and conclusion clearer.

Compare markets without forcing them into one schema

For a cross-market view, preserve four layers:

1. the shared versioned product facts;
2. the official local class and terminology;
3. a normalized comparison label where a defensible mapping exists;
4. the rule, source, uncertainty, and date for each market.

This structure lets you compare outputs while respecting genuine differences. A missing class in a public registry also does not mean the market lacks classification rules; it may mean that the source does not publish the field.

A quick quality check

Before using the proposed class, confirm that:

• the intended purpose and key technical characteristics are complete;
• every market received the same version of those facts;
• the result identifies the local rule or rationale;
• unresolved facts are visible instead of guessed;
• comparable registrations were checked for true technical similarity;
• local raw class and normalized class are not confused;
• the result is described as research support when expert or authority confirmation is still needed.

The benefit of the tool is not a universal one-click class. It is a fast, consistent way to test the same product context against different market rules and keep the reasoning available for review.