Why we built MDClassify

MDClassify runs the same Annex VIII logic a consultant would apply by hand, and shows its work: which rule matched, what it produced, and why. You get an indicative answer in minutes instead of days, in a form you can discuss with your regulatory advisor rather than a bare letter you have to take on faith.

MDClassify is built and maintained by V22 Media. V22 Media is the regulatory and digital practice behind MDClassify, working with medical device manufacturers on EU MDR conformity, technical documentation and market access.

That matters for two reasons. The first is that the engine was written by people who do this work by hand, so its conservatism is deliberate: where Annex VIII requires interpretation rather than logic — the nanomaterial exposure assessment, the question of whether an incorporated substance acts principally or ancillarily, borderline qualification, an intended purpose that does not quite match the marketing claims — the tool stops and says so instead of guessing. Which rules those are is set out one by one, with the two branches not yet implemented named, on the regulatory framework page.

The second is that the tool is free and stays free. It exists because the preliminary classification conversation is one we have constantly, and automating it means the conversations we do have can start somewhere more useful. If your device turns out to be Class IIa or above, or the tool flags it for review, you know where to find us.

The result is indicative and informational. It is not regulatory advice, not a conformity assessment, and not binding on any Notified Body or Competent Authority — responsibility for classifying a device and documenting the rationale stays with the manufacturer under Article 10 of the Regulation.

For a reviewed classification, a technical documentation gap analysis, or a second opinion on a result from this tool, write to service@mdclassify.com.