Software under EU MDR: From Intended Purpose to Class

Two questions decide everything else about a piece of medical software: whether it is a device at all, and which class it falls into. This guide works through both in the order the regulation asks them, and gives you the templates to answer them in a form that belongs in a technical file.

Every substantive claim is referenced to a specific article or guidance section, and the citation index at the end lets you find the reference again without rereading the guide. Where a judgement is genuinely contestable, the guide says so rather than giving you false certainty.

What is inside

• Part 1 — Qualification: is it a device at all?The five decision steps, where the “simple search” line falls, and why risk of harm is not a qualification criterion.
• Part 2 — The intended purpose statementThe five elements a statement must contain, a fill-in template, and one product written three ways with three different regulatory outcomes.
• Part 3 — Classification: which class?Rule 11 in plain terms, a one-page decision tree you can print, six worked examples, and the implementing rules that can override the answer Rule 11 gives you.
• Part 4 — If your software uses AIWhere the MDR and the AI Act stack, what your technical file is missing, and the Notified Body designation question to ask in writing.
• Part 5 — ModulesOne product with several regulatory statuses, the modules you cannot leave outside the boundary, and why a feature flag can change your obligations.
• Appendix — Citation indexEvery provision used, grouped by what you are trying to find: MDR, IVDR, AI Act, MDCG 2019-11 Rev.1 and the relevant standards.

This guide does not constitute regulatory advice and does not replace a Notified Body or a qualified regulatory professional. What it does is get you to that conversation prepared.