#Clinical Safety Boundary Statement

The answer, in one sentence: Pensieve is a hospital operating system, an administrative and record-management platform, and is not a medical device in India, the European Union and the European Economic Area, Australia, or the United Arab Emirates. This document states why, names the provision it relies on in each jurisdiction, and publishes the feature-level boundary that keeps it true.

---

#Applicability

Regulatory status attaches to what the software does and what its manufacturer says it is for. It does not change with where it is hosted. The position is therefore identical in all four models.

---

#Purpose

A hospital's Director of Clinical Governance, quality manager or medical superintendent will ask whether the software is a regulated medical device. It is a question with real consequences: a regulated device requires registration, a licence or a conformity assessment before supply, a quality management system, post-market surveillance and adverse-event reporting. A vendor who has not thought about it is a risk to the hospital, because the hospital is the one deploying the software into clinical care.

This document exists so the answer is "no, and here is the provision" rather than "we don't think so". It is also a binding internal design constraint: Section 7 is enforced at the design gate described in DIS-GL-018 Section 5.1, before a feature is built, not after.

---

#1. The principle that decides every case

Every jurisdiction in Pensieve Labs's portfolio draws the line in substantially the same place, using different words. Reduced to one test:

If a competent clinician can see the input, see the rule, and see the output, and would reach the same conclusion without the software, it is information management.

If the software applies a model or a clinical judgement of its own, and the clinician is expected to rely on the output without independently reviewing its basis, it is a medical device.

The corollary, and the design rule that follows from it: transparency is the safe harbour. Show the source. Show the rule. Let the clinician decide. Pensieve is built to that rule, and the rule is enforced at design review rather than argued after release.

The second principle, which is the one vendors get wrong: in every jurisdiction, intended purpose is determined by what the manufacturer says. A marketing sentence, a user-interface label, a data sheet, a tender response or a contract term can regulate a product that the code does not. Copy review is therefore part of the same gate (Section 8).

---

#2. India: Medical Devices Rules, 2017 and the CDSCO software guidance

Position: Pensieve is outside the scope of the Medical Devices Rules, 2017. No CDSCO licence is required and none is held.

#2.1 The frame

Software is regulated in India as a medical device under the Medical Devices Rules, 2017, made under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organisation issued Draft Guidance on Medical Device Software on 21 October 2025; stakeholder consultation is complete and it remains in draft as at 31 July 2026. The guidance clarifies how the existing Rules apply to software across its lifecycle and does not create new requirements (Cyril Amarchand, Medical Device as Software: Has CDSCO Guidance Changed the Rules?; Asia Actual: India releases draft guidance on medical device software).

That last point matters and is stated rather than glossed: because the guidance is clarificatory, the risk it describes existed before it was published. No vendor can say it was compliant until October 2025.

#2.2 The exclusion Pensieve relies on

The draft guidance explicitly excludes from medical-device scope:

• Administrative systems: hospital management information systems
• Electronic medical records
• General health information software
• Fitness and wellness applications

A hospital operating system performing registration, admission, discharge and transfer, billing, revenue cycle, inventory, pharmacy stock, procurement, human resources, scheduling, theatre and bed management, claims, analytics and clinical record-keeping falls squarely inside that exclusion.

#2.3 Where the line is crossed

Software becoming Software as a Medical Device is classified on two criteria: the significance of the information provided to the healthcare decision, and the seriousness of the healthcare situation addressed. Software guiding treatment decisions in critical situations lands in Class C or D; software supporting non-serious clinical management in Class A or B. Class A and B are licensed by the State Licensing Authority, Class C and D by the Central Licensing Authority, through the Sugam portal, with licences valid for five years subject to the retention fee. [UNVERIFIED: the exact application and licence form mapping for domestic manufacture versus import across Class A/B and C/D should be confirmed against cdsco.gov.in before any filing.]

The consequence of crossing the line is not a form. It is a quality management system, a licence, post- market surveillance, adverse-event reporting and a five-year licence cycle. That is a different company, and Pensieve Labs says so plainly rather than implying the transition would be administrative.

---

#3. European Union and European Economic Area: MDR 2017/745 and MDCG 2019-11 Rev.1

The operative memorandum for an EU or EEA hospital is DIS-EU-028 (Clinical Safety Boundary Statement: EU), which carries the Rule 11 trigger list with the EEA-build exclusions named, the third-party device display rules, the customer-as-manufacturer consequence, and the boundary against the EHDS conformity regime. This section states the shared principle; DIS-EU-028 is what a European medical device or quality function asks for.

Position: Pensieve is not a medical device under Regulation (EU) 2017/745. The platform is a hospital information system, which the Medical Device Coordination Group's own guidance states is not qualified as a medical device.

#3.1 The qualification carve-out

MDCG 2019-11 states that hospital information systems are not qualified as medical devices, while noting that they may be used together with other products that are (MDCG 2019-11). The classic carve-out covers software that only stores, archives, communicates, performs lossless compression or does simple search, which is the substrate a hospital operating system provides.

MDCG 2019-11 Rev.1 was published in June 2025. The revision matters to Pensieve specifically because it updates the treatment of modules and their interplay with electronic health record systems under the European Health Data Space, and adds artificial-intelligence examples (BioSlice Blog; GMP Insiders).

#3.2 Rule 11: where a hospital operating system becomes a device

Rule 11 of Annex VIII classifies software intended to provide information used to take decisions for diagnostic or therapeutic purposes. Applied to the features a hospital asks for:

#3.3 The module argument, and why Pensieve Labs does not need it

Under the Rev.1 module guidance, a device module can be assessed separately from the non-device platform. That is a legitimate architecture and it is the one Pensieve Labs would use if it ever built such a module, as a separately assessed, separately branded product integrated by interface, so that the core platform's regulatory status is not contaminated.

It does not build one today. Pensieve ships no feature in the right-hand column of Section 3.2, in any market. A hospital in Denmark or Norway asking for the qualification memorandum should read this document together with Section 7, which is the feature-level version of the same statement.

A note on the European Health Data Space. Regulation (EU) 2025/327 entered into force on 26 March 2025. It converts electronic-health-record-system conformity from a market expectation into a self-declaration regime with a manufacturer's declaration of conformity and technical documentation, which is a materially different obligation from medical device conformity assessment, and one Pensieve Labs intends to meet on its statutory timetable. A claim circulating in secondary sources that electronic health record systems must be certified from January 2026 is not supported by the Regulation's own timeline and Pensieve Labs does not repeat it. [UNVERIFIED: treat the secondary claim as wrong; the operative dates are in the Regulation.]

---

#4. Australia: Therapeutic Goods Act 1989 and the Excluded Goods Determination

Position: Pensieve is EXCLUDED from TGA regulation, not exempt. It relies on five named exclusion items in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018.

#4.1 Excluded is categorically better than exempt

Software-specific exclusions were inserted into Schedule 1 by the Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021, alongside classification rules for software-based medical devices effective 25 February 2021. There are now 15 software exclusion categories in that Schedule (TGA: software-based medical device exclusions).

#4.2 The five items Pensieve stands on

Sources: TGA guidance on the electronic health records exclusion, the population-based analytics exclusion, the laboratory information management exclusion, and the health alert systems exclusion. [UNVERIFIED: the item letters should be confirmed against the current Determination text before being cited in a tender response. The five items above were each corroborated from two independent retrievals.]

#4.3 The disqualifying condition, which is the same for all five

Software falls out of every one of these exclusions if it is intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, defect or ailment, or if it is intended to replace the clinical judgement of a health professional.

Section 7 is the feature-level expression of that condition, and it is why Pensieve ships no scoring, no dose calculation and no image analysis in any market, not only in Australia.

#4.4 The alarm carve-out, stated precisely

TGA guidance on item 14I is explicit that the exclusion does not apply to software that provides alarms to health professionals that must be actioned urgently; the example given is a ventilator alarm requiring an ICU nurse to act immediately.

Product rule, absolute: Pensieve is never the delivery path for a time-critical clinical alarm. No physiological monitor alarm routing, no code-blue paging derived from device signals, no deterioration escalation triggered by vital-sign thresholds. Where a hospital asks for it, the answer is that Pensieve integrates with the system that does it and records the event; it does not originate it. This one line preserves the entire exclusion position, and it appears in the exclusions list on the Order Form, not only in this policy.

#4.5 Why Pensieve Labs does not rely on the clinical decision support exemption

The 2021 reforms also created an exemption for clinical decision support software. Exempt is not excluded: an exempt device is still a medical device, and the manufacturer remains subject to advertising restrictions, adverse-event reporting and TGA notification.

Pensieve Labs does not build to the exemption. Relying on it would convert Pensieve from an unregulated product into a regulated-but-relieved one, import post-market vigilance obligations, and, most damaging commercially, turn "is this a medical device?" into a question with a nuanced answer instead of a one-word one. Pensieve Labs stays inside 14G, 14M, 14N, 14O and 14I, where the answer is "no, and here is the item number."

---

#5. United Arab Emirates

Position: Pensieve is an administrative and record-management platform and is not marketed, labelled or supplied as a medical device in the UAE. It performs no diagnostic, monitoring, scoring or treatment-recommendation function, in the UAE or anywhere else.

The functional boundary in Section 7 is the same in every market, so the substantive answer does not change. What differs in the UAE is the surrounding regulatory environment: health data localisation under Federal Law No. 2 of 2019 Article 13, and health-authority licensing and health-information-exchange participation requirements, and those are addressed in DIS-GL-008 Section 6 and DIS-GL-024, not here.

[UNVERIFIED: Pensieve Labshas not obtained a formal classification opinion from a UAE health authority. The position stated is that the product performs no function that would engage medical-device regulation in any ofPensieve Labs's markets. A UAE buyer requiring a formal local classification opinion should raise it at qualification; Pensieve Labs will support the application with the technical file and will not assert a position it has not obtained.]

DIS-AE-028 is the UAE cover note. It states the local registration frame, the evidence Pensieve Labs puts forward in place of a local opinion, and the express distinction between an interoperability vendor assessment and a medical-device registration. Send it, not this section, to a UAE reviewer.

---

#6. The one-line answer per market

Edsol Edtech Pvt. Ltd. holds no ISO 13485 certification and no IEC 62304 conformity declaration, and seeks neither. They are the quality-system standards for medical device manufacture, and Pensieve is not a medical device. WPR-GL-005 Section 6.1 records this in the same terms.

---

#7. The feature boundary: what Pensieve will and will not do

This table is a binding product-design constraint, not a description. It is enforced at the design gate in DIS-GL-018 Section 5.1, before a feature is built. A hospital may hold Pensieve Labs to every line of it, and ADD-GL-005 carries the contractual use restrictions that correspond.

#7.1 What Pensieve does not do

#7.2 What Pensieve does do, and why it stays inside the line

---

#8. Language control

Because intended purpose is set by what the manufacturer says, language is a regulated surface and is controlled like one.

---

#9. What a hospital must do: the shared boundary

Pensieve's regulatory status depends partly on how the hospital deploys and describes it.

---

#10. If Pensieve Labs ever wanted to cross the line

Stated so that the boundary reads as a decision rather than an incapacity.

A clinical feature that falls outside these boundaries would be built as a separately licensed, separately branded module with its own regulatory approval and its own risk classification, integrated by interface. It would not be added to the core platform, because doing so would convert Pensieve into a regulated medical device in four jurisdictions simultaneously, with a quality management system, a licence or conformity assessment, post-market surveillance and adverse-event reporting attached.

There is no such module today, no such module in development, and no commitment to build one. If that changes, this document changes first, and the change is published in DIS-GL-010-style before the feature ships, not after.

---

#11. Limitations

11.1 This is Edsol Edtech Pvt. Ltd.'s own regulatory position, not a regulator's ruling. No competent authority in any of Pensieve Labs's markets has issued a formal classification decision on Pensieve. The position is reasoned from published guidance and named provisions, which is the normal basis on which a non-device software product operates, and it is not the same as a determination.

11.2 The Indian guidance is in draft. Section 2.1. It is clarificatory rather than new, so Pensieve Labs's position does not depend on the draft being finalised in its current form, but a material change on finalisation would be published here.

11.3 Item numbers and provision references should be verified before citation in a tender. Section 4.2 carries an [UNVERIFIED] marker on the Australian item letters. Pensieve Labs will confirm them against the current Determination on request, and does not want a buyer citing an item number that has moved.

11.4 No formal EU qualification memorandum has been issued yet. A Danish or Norwegian buyer will ask for an MDR qualification and classification memorandum module by module. Pensieve Labs will produce one on request; it is not published as a standing artefact today, and the position it will state is Section 3.

11.5 No UAE classification opinion. Section 5.

11.6 The boundary depends on continued enforcement. Section 7 is only true while the design gate holds. The gate is described in DIS-GL-018 Section 5.1, it is not independently audited, and a hospital relying on this document should note that its assurance is Pensieve Labs's process and its published word, not a third party's verification.

11.7 This document is not legal or regulatory advice to the hospital. Whether a hospital's own use of Pensieve, or its own configuration of it, engages an obligation on the hospital is a question for the hospital and its advisers.

---

#12. Related documents

---

#13. Change history

---