Vendor track · Module 2 · 45 min
Is It a Medical Device?
Turn the fact base into a disciplined qualification assessment: intended purpose as the regulatory anchor, the EU Medical Device Regulation (MDR) Article 2(1) medical-purpose families, the Medical Device Coordination Group (MDCG) software qualification sequence, device and accessory linkage, the specimen-gated MDR/In Vitro Diagnostic Medical Devices Regulation (IVDR) boundary, and a red-team pass over the story before you rely on it.
After this module you can
Turn the fact base into a disciplined qualification assessment — signals, linkages, boundary questions and open questions rather than false certainty.
- Explain why intended purpose anchors qualification and later classification
- Recognise all EU Medical Device Regulation (MDR) Article 2(1) medical-purpose families, not only diagnosis and treatment
- Distinguish wellbeing, administration and documentation tools from disease-specific or patient-specific purposes
- Apply the Medical Device Coordination Group (MDCG) software qualification sequence in order
- Treat device and accessory linkage as non-terminal
- Enter the In Vitro Diagnostic Medical Devices Regulation (IVDR) boundary branch only where specimen or in vitro diagnostic (IVD) linkage actually exists
- Stress-test restrictive wording, technical controls, feature names, carve-outs and commercial claims
- Say when remaining uncertainty requires professional regulatory review
Module 3 teaches classification reasoning. It starts only once the qualification premise here is stable enough to state.
This course is educational decision support for vendors and is not legal advice. It structures regulatory reasoning and produces learner-authored working positions. It does not tell you whether your product is a medical device, whether MDR or IVDR applies, what class it is, which conformity route applies, whether a notified body is required, or whether your AI system is high-risk under the AI Act, and it produces no compliance or readiness score. It does not replace a competent regulatory review. MDCG and AI Board guidance is cited throughout because it is the practical reference practitioners use, but it is not binding law: only the regulations themselves bind, and only the Court of Justice of the European Union gives binding interpretations of them. Regulatory basis reviewed: 18 September 2026.
Step 1
Intended purpose is the regulatory anchor
Under the MDR, whether software is a medical device begins with what the manufacturer intends it to be used for, and classification rules are governed by intended purpose too. That makes it the bridge between product design, claims, evidence, risk management and the regulatory route — not a marketing sentence.
A usable draft answers: what the function does; who uses it; for whom; what input and output matter; what objective is pursued; and how the output is expected to influence action. Specific enough to support qualification, not padded with claims the product cannot evidence.
Two traps are common. Writing the purpose around the desired regulatory outcome — “provides information” instead of “predicts deterioration risk”, product unchanged. Or the opposite: sales copy grows faster than the regulatory position and introduces a claim the evidence and route were never built to support. Using your saved Module 1 profile, draft the purpose from the facts, then compare it with the claims you already recorded.
The Builder drafts wording and surfaces regulatory relevance signals. It stops before formal MDR/IVDR qualification or classification, and it never outputs a device status, a framework or a class.
Use your Product Regulatory Profile
No saved profile yet. You can still prefill from what you entered in Module 1, or complete Module 1 first.
0 of 8 steps complete
- A · Product boundary — Not written yetNot written yet
- B · Workflow and context — Not written yetNot written yet
- C · Claims inventory — Not written yetNot written yet
- D · Draft intended purpose — Not written yetNot written yet
- E · Qualification assessment — Not written yetNot written yet
- F · Classification position — Not written yetNot written yet
- G · Conformity strategy — Not written yetNot written yet
- H · Clinical evidence plan — Not written yetNot written yet
- I · EU AI Act overlay — Not written yetNot written yet
- J · QMS and lifecycle plan — Not written yetNot written yet
Your own writing, section by section. Nothing here is scored, and no section states device status, a class, a route or readiness.
Sources & evidence · 8 sources
This module cites primary legal, public or consensus guidance.
Content reviewed: September 2026. Publication dates of the individual sources are shown in each citation.
Regulation (EU) 2017/745 (MDR), consolidated text 02017R0745 — 19.07.2026
Article 2(1) and 2(12) definitions; Article 10 manufacturer obligations; Article 15 PRRC; Article 52 and Annexes IX–XI conformity assessment; Article 61 and Annex XIV clinical evaluation; Annex II technical documentation; Annex VIII implementing rules and Rule 11.
Open sourceRegulation (EU) 2017/746 (IVDR), consolidated text 02017R0746 — 10.01.2025
Article 2(2) in-vitro diagnostic definition and Article 2(4) accessory definition.
Open sourceRegulation (EU) 2024/1689 (AI Act), consolidated text — 27.07.2026
Article 3 definitions and actor roles, Article 6 high-risk classification routes, Articles 8–15 requirements for high-risk AI systems, Article 25 value-chain responsibilities and the transitional provisions.
Open sourceMDCG 2019-11 rev.1, Qualification and Classification of Software in MDR and IVDR — June 2025
Figure 1 and Figure 2 decision sequences, §3.1–3.3, §4.2.1, Annex II examples and Annex IV classification examples.
Open sourceMDCG 2021-24 rev.1, Guidance on classification of medical devices — April 2026
Supplementary Rule 11 teaching examples. Used as illustrative context, not as a determination.
Open sourceMDCG 2020-1, Clinical evaluation of medical device software
Valid clinical association, technical performance and clinical performance as the structure of a software evidence plan.
Open sourceMDCG 2025-10, Post-market surveillance guidance
Used for the surveillance, PMCF and vigilance loop taught in Module 7.
Open sourceMDCG 2025-6 / AIB 2025-1, interplay between the MDR/IVDR and the AI Act
Used for how the two frameworks sit alongside each other, including integrated documentation and conformity work.
Open source