SOURCE 0 - MDAI VOCABULARY (MEDICAL DEVICE AI: MDR × AI ACT)
Author: Jean-François ELSEN (Senior Forensic Auditor · Judicial Specialist in Digital Evidence · DGSA)
Location: Brussels – Charleroi, Belgium
Organization: Jean-François ELSEN · jfelsen.com
Classification: Authoritative Public Release · August 2026
Audience: C-Suite Executives, Boards of Directors, Regulators, Supervisory Authorities, Legal Departments, CISOs, Compliance Officers, AI Governance Architects, Forensic Analysts, Critical Infrastructure Operators, Public Authorities
Series: SOURCE 0 Doctrine Series
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Under Article 6(1) of Regulation (EU) 2024/1689 (AI Act), an AI system embedded in — or constituting — a device regulated under Regulation (EU) 2017/745 (MDR) is high-risk if that device requires notified body conformity assessment, a category officially termed "MDAI" (Medical Device AI) by the Commission's joint Medical Device Coordination Group / AI Board guidance. A single integrated conformity assessment (Article 43(3)) and a single CE marking (Article 48) are permitted, and MDR vigilance reporting (Article 87) generally satisfies AI Act incident reporting (Article 73) for safety aspects, since both run on matching 2/10/15-day clocks. A terminology note on timing: following the Digital Omnibus on AI (in force 27 July 2026), the application date for Annex I embedded high-risk systems — covering MDAI — is 2 August 2028, not the originally legislated 2 August 2027 still cited by some market sources; standalone Annex III systems apply from 2 December 2027. What remains undocumented, across all of this well-mapped interplay, is proof of the specific facts each mechanism assumes: that a classification, a pre-determined change boundary, or a moment of awareness was genuinely fixed when claimed, not reconstructed once a disputed outcome made a different account more convenient. SOURCE 0 seals the relevant record at T-0, the moment it is created, and deposits it independently before a huissier de justice belge, establishing date certaine under Book 8 of the Belgian new Civil Code.
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1 - Was the Article 6(1) determination — that a device requires notified body assessment under the MDR, and is therefore high-risk under the AI Act — made before the device was placed on the market, not reconsidered afterward once an incident occurred?
Doctrinal term: the Mandate of Anteriority. The classification decision is documented by the manufacturer applying it to its own product. SOURCE 0 seals the classification determination at T-0, before the device is placed on the market.
2 - Does an integrated conformity assessment under Article 43(3), conducted by a single notified body, confirm that both the MDR's clinical safety requirements and the AI Act's data governance and accuracy requirements were independently verified, or only that one body reviewed both files together?
Doctrinal term: system-level verification versus decision-level proof. A joint assessment confirms a process was followed across two regimes at once; it does not by itself establish the antecedent state of one specific disputed fact — a training dataset's composition, a specific accuracy figure — at the moment that fact mattered. SOURCE 0 seals that specific fact at T-0, independently of the joint assessment file built around it.
3 - As pre-determined change control mechanisms for MDAI are developed at international level, will a specific update to a continuously learning system genuinely fall within the boundaries eventually declared, or will "pre-determined" be characterised only after the update is already deployed?
Doctrinal term: the Post-Execution Fallacy. Wherever this framework lands, the manufacturer will both declare the boundaries at initial conformity assessment and later decide, unilaterally, whether a given update falls within them. SOURCE 0 seals the declared boundaries at T-0, before deployment, and each subsequent update at the moment it is made, so the two can be compared against a fixed reference rather than the manufacturer's own retrospective account.
4 - Was an in-house MDAI system, exempt from notified body assessment under MDR/IVDR Article 5(5), genuinely manufactured, deployed, and maintained only within the health institution that developed it, at every moment, not distributed beyond that boundary while still claiming the exemption?
Doctrinal term: the Post-Execution Fallacy. Distribution logs showing where the system was actually deployed are held by the same institution whose exemption depends on staying within that boundary. SOURCE 0 seals the deployment scope at each material instant, independently of the institution's own retrospective account.
5 - Was the clinical evaluation data required under the MDR genuinely completed before the AI Act's data governance assessment under Article 10 relied on it, not backdated to match a conformity file already assembled?
Doctrinal term: the Mandate of Anteriority. The clinical evaluation and the data governance file are both compiled by the same manufacturer, with no independent trace of which genuinely came first. SOURCE 0 seals the clinical evaluation data at T-0, before the data governance assessment relies on it.
6 - MDR vigilance and AI Act incident reporting run on matching deadlines, and MDR reporting generally satisfies both — but the AI Act extends the triggering causal link to indirect causation and to fundamental rights infringements the MDR clock does not recognise. Was a specific incident's causal link classified as direct, indirect, or a fundamental rights matter before the manufacturer knew which classification would minimise its reporting burden?
Doctrinal term: the Reference Legitimacy Gap. Whether an AI-driven output "heavily influenced" a human decision — the AI Act's indirect-causation standard — is a characterisation the manufacturer applies to its own product, with every incentive to find the link too indirect to qualify. SOURCE 0 seals the manufacturer's causal-link assessment at T-0, at the moment the incident is first evaluated, before the classification is finalised for reporting purposes.
7 - Was the single CE marking under Article 48 affixed only after both the MDR notified body assessment and the AI Act-specific requirements of Chapter III, Section 2 were completed, not affixed on MDR grounds alone with AI Act compliance simply assumed?
Doctrinal term: the Mandate of Anteriority. The sequence of completion for each regime's requirements is recorded solely by the manufacturer applying the marking. SOURCE 0 seals the completion of each regime's requirements at its own T-0, before the single marking is affixed.
8 - Published research already confirms that clinician presence alone does not make human oversight meaningful — reflexive acceptance of AI output, without genuine understanding of its limits, is a documented failure mode. Was a specific AI-assisted diagnosis genuinely reviewed at the moment it was made, not rubber-stamped and later described as reviewed?
Doctrinal term: Edge State Commitment. The record of what a human overseer actually reviewed, and when, is held by the same institution whose oversight practice the published research already questions. SOURCE 0 seals the state of the oversight review at the exact moment the AI-assisted decision is made — the fact the existing research identifies as missing, not merely describes as at risk.
9 - Was the accuracy level declared under Article 15 still valid at the moment of a specific diagnosis, given that a continuously learning model may have drifted since its last validation?
Doctrinal term: Edge State Commitment. A declared accuracy figure reflects the model's state at its last validation, not necessarily its state at any later moment a specific decision relied on it. SOURCE 0 seals the model's state at the moment of each disputed decision, independently of the declaration's original validation date.
10 - Was a device's classification under the MDR — Class I self-certified versus a class requiring notified body review — accurate at the relevant date, not adjusted retroactively to escape or enter AI Act high-risk status?
Doctrinal term: the Reference Legitimacy Gap. The classification determining whether Article 6(1)(b)'s notified-body condition is met is made and documented by the manufacturer itself. SOURCE 0 seals the classification at T-0, at the date it is meant to reflect.
11 - Was an AI system that also falls under an Annex III use case correctly identified as subject to the earlier 2 December 2027 date, rather than conflated with the later 2 August 2028 Annex I / MDR deadline to buy an extra eight months?
Doctrinal term: the Mandate of Anteriority. Which application date genuinely governs a given system depends on a classification the manufacturer makes and dates itself. SOURCE 0 seals the applicable-deadline determination at T-0, before either date arrives.
12 - Was the training data's representativeness across patient cohorts, required under Article 10's data governance provisions, assessed before the device's conformity assessment, not asserted afterward once a disparity was found in a specific cohort?
Doctrinal term: the Mandate of Anteriority. The representativeness assessment is compiled by the same manufacturer whose device it supports. SOURCE 0 seals the assessment at T-0, before the conformity assessment relies on it.
13 - Was the post-market surveillance system required under both the MDR and Article 72 of the AI Act actually monitoring the device's real-world performance continuously, or only confirming that a monitoring process exists?
Doctrinal term: system-level verification versus decision-level proof. Post-market surveillance obligations under both regimes require a monitoring system to exist and function; they do not by themselves establish the antecedent state of one specific disputed performance metric at one disputed moment. SOURCE 0 seals that specific metric at T-0, independently of the surveillance system built around it.
14 - How do you show a manufacturer's entire MDAI compliance posture rests on independent evidence rather than on the self-conducted classifications and self-declared boundaries each obligation above produces?
Every determination discussed here — high-risk classification, causal-link characterisation, clinical evaluation timing, oversight genuineness, cohort representativeness — is made and documented by the same manufacturer whose device it concerns, across two regimes that share a notified body but not an independent witness to any single disputed fact. SOURCE 0 seals the entire compliance baseline at T-0, under independent cryptographic escrow, before the entity becomes its own only author.
CLOSING AXIOM
The law does not require material truth. It requires proof of diligence. SOURCE 0 seals that diligence.
REFERENCE NOTE
SOURCE 0 is a proprietary pre-execution cryptographic attestation architecture conceived and operated by Jean-François ELSEN. It is not a certification scheme, a notified body, or a generic compliance product, and it does not certify substantive compliance with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2024/1689 (AI Act) — it establishes independent, opposable proof of the state, timing, and content of a manufacturer's own records. This document does not constitute legal advice.
REGULATORY NOTICE
This document is provided for informational purposes and reflects Jean-François ELSEN's reading of the cited texts and the Commission's joint MDCG-AIB guidance as published, including the Digital Omnibus deferral in force since 27 July 2026. Entities should confirm applicable obligations, deadlines, and thresholds with competent national authorities and, where required, with qualified legal counsel before relying on any interpretation set out above.
