FINAL ANSWER PACK
OrderCheck HCP 0.6 — Answer Pack
Example Clinical · assessed 2026-08-21 · reference SAMPLE-FICTIONAL-0000
- Reviewed scope
- Medical-device qualification and Apple / Google declaration fields
- Markets
- United States · Great Britain · EU / EEA + Northern Ireland
- Functions
- Prescribing recommendation for a healthcare professional
Decision
Your result at a glance
Each card answers the same question for a different market.
United States
Your result
Not a medical deviceWhat this means
The reviewed software function is not treated as a medical device in the United States on the facts assessed.
Why we reached it: The reviewed function “Prescribing recommendation for a healthcare professional” did not meet the United States test shown in the detailed record.
Great Britain
Your result
Medical deviceWhat this means
The reviewed product meets Great Britain’s medical-device definition on the facts assessed.
Why we reached it: The reviewed function “Prescribing recommendation for a healthcare professional” met the Great Britain test shown in the detailed record.
EU / EEA + Northern Ireland
Your result
Medical-device softwareWhat this means
The reviewed software performs a medical purpose and meets the EU/NI test for medical-device software.
Why we reached it: The reviewed function “Prescribing recommendation for a healthcare professional” met the EU / EEA + Northern Ireland test shown in the detailed record.
- Layer 1 qualification differs: the EU result is regulated, while the US result is not a device.
- Layer 1 qualification differs: the GB result is regulated, while the US result is not a device.
See the detailed reasoning and official sources for the reviewed market results
Action
Your store-submission steps
These are organized by the two stores—not by market. Any market-specific value sits inside its store card.
Apple App Store · Medical device declaration
READY TO ENTER
Where: App Store Connect → App Information → App Store Regulations & Permits → Declare Regulated Medical Device
Field: Regulated medical device status for each listed country or region
- United States
- No
- Great Britain
- Yes
- EU / EEA + Northern Ireland
- Yes
Why: Apple asks for regulated medical-device status separately for each distribution region.
Google Play · Health apps declaration
READY TO ENTER
Where: Play Console → Policy → App content → Health apps → Start
Field: Health apps declaration → Medical Device Apps
Medical device appsWhy: Google uses one Health apps category declaration; it does not repeat Apple’s regional Yes/No format.
Using this pack
Two independent store forms
Apple and Google are not steps in a sequence. Use each card for its own platform form.
Need to explain or challenge a result? The detailed record preserves the reasoning and official sources.
Record controls
Version and saved copy
Document revision: 1 · DD-ANSWER-PACK-1
Assessment version details
Assessment engine: United States · Great Britain · EU/NI qualification engine · Engine version: 0.6 · Rules snapshot: rules/DD_rules_01_qualification.md + rules/DD_rules_02_gb_qualification.md + rules/DD_rules_03_us_qualification.md
Assessment version details
Assessment engine: United States · Great Britain · EU/NI qualification engine · Engine version: 0.6 · Rules snapshot: rules/DD_rules_01_qualification.md + rules/DD_rules_02_gb_qualification.md + rules/DD_rules_03_us_qualification.md
Record
Detailed record — keep for your files
Use this appendix when you need to verify why a result was reached, answer a store or reviewer question, or request a correction. You do not need its technical codes for the normal submission steps.
1Do I need to complete the store forms?
These are platform requirements, not legal classifications. Apple and Google ask different questions, so the two form formats are not identical.
Apple App Store
Required
Apple asks for a separate regulated-medical-device Yes/No answer for each distribution region.
Google Play
Required
Google asks every published or testing app to complete one Health apps declaration and choose its health-feature categories.
Internal platform mapping record
These are Declaration Desk mapping keys, not Apple or Google field values.
Apple: APPLE_DISTRIBUTION_REGION_PRESENT, APPLE_CATEGORY_TRIGGER_MET, APPLE_MEDICAL_FREQUENCY_TRIGGER_NOT_MET
Google: GOOGLE_ALL_DEVELOPERS_INCLUDING_NO_HEALTH_FEATURES
Internal platform mapping record
These are Declaration Desk mapping keys, not Apple or Google field values.
Apple: APPLE_DISTRIBUTION_REGION_PRESENT, APPLE_CATEGORY_TRIGGER_MET, APPLE_MEDICAL_FREQUENCY_TRIGGER_NOT_MET
Google: GOOGLE_ALL_DEVELOPERS_INCLUDING_NO_HEALTH_FEATURES
2Decision record by market
| Market | Result | Why |
|---|---|---|
| United States | Not a medical device | The function recorded in this assessment did not meet the United States test shown in the detailed record. |
| Great Britain | Medical device | The function recorded in this assessment met the Great Britain test shown in the detailed record. |
| EU / EEA + Northern Ireland | Medical-device software | The function recorded in this assessment met the EU / EEA + Northern Ireland test shown in the detailed record. |
- Layer 1 qualification differs: the EU result is regulated, while the US result is not a device.
- Layer 1 qualification differs: the GB result is regulated, while the US result is not a device.
Internal market control record
These are saved engine controls, not legal citations and not customer-facing result labels.
- United States · Not a medical device
NOT_A_DEVICE_US - Great Britain · Medical device
MEDICAL_DEVICE_GB - EU / EEA + Northern Ireland · Medical-device software
MDSW_PRESENT
US oversight posture: Not applicable to this resultNOT_APPLICABLE
US status reasons: None recorded
US recorded reason: All assessed functions ended outside the US device definition or in a statutory exclusion on complete evidence.
Internal market control record
These are saved engine controls, not legal citations and not customer-facing result labels.
- United States · Not a medical device
NOT_A_DEVICE_US - Great Britain · Medical device
MEDICAL_DEVICE_GB - EU / EEA + Northern Ireland · Medical-device software
MDSW_PRESENT
US oversight posture: Not applicable to this resultNOT_APPLICABLE
US status reasons: None recorded
US recorded reason: All assessed functions ended outside the US device definition or in a statutory exclusion on complete evidence.
3Internal technical support record
You do not need this section for a normal store submission. It preserves Declaration Desk’s internal trace codes so we can reproduce, challenge or correct the result later.
Internal trace record
These are internal engine codes, not legal citations and not values to enter in Apple or Google.
| Function | United States | Great Britain | EU / EEA + Northern Ireland |
|---|---|---|---|
| Prescribing recommendation for a healthcare professional | Not a medical deviceNOT_A_DEVICE_US | Medical deviceMEDICAL_DEVICE_GB | EU medical-device software pathway under the MDRMDSW_MDR |
Prescribing recommendation for a healthcare professional — recorded purpose and data sources
Purpose selection. State One or more recorded selections are setSET · values Disease-related purposedisease
Data sources. State No selection was recordedBLANK · values [] · derived basis Not recorded
Great Britain purpose branches
| Purpose | State | Outcome | Resolution path | Reason |
|---|---|---|---|---|
Disease-related purposedisease | Established branchESTABLISHED | Medical deviceMEDICAL_DEVICE_GB | Not recorded | The function has a GB statutory medical intended purpose and operates independently. |
Internal trace record
These are internal engine codes, not legal citations and not values to enter in Apple or Google.
| Function | United States | Great Britain | EU / EEA + Northern Ireland |
|---|---|---|---|
| Prescribing recommendation for a healthcare professional | Not a medical deviceNOT_A_DEVICE_US | Medical deviceMEDICAL_DEVICE_GB | EU medical-device software pathway under the MDRMDSW_MDR |
Prescribing recommendation for a healthcare professional — recorded purpose and data sources
Purpose selection. State One or more recorded selections are setSET · values Disease-related purposedisease
Data sources. State No selection was recordedBLANK · values [] · derived basis Not recorded
Great Britain purpose branches
| Purpose | State | Outcome | Resolution path | Reason |
|---|---|---|---|---|
Disease-related purposedisease | Established branchESTABLISHED | Medical deviceMEDICAL_DEVICE_GB | Not recorded | The function has a GB statutory medical intended purpose and operates independently. |
4What evidence was reviewed?
| Channel | Status | Reference |
|---|---|---|
| App-store description and category | Reviewed | App Store listing / 2026-08-21 |
| Product website / landing page | Reviewed | Product website / 2026-08-21 |
| In-app onboarding, screens and results | Reviewed | Recommendation screen / 2026-08-21 |
| Advertising, repeated testimonials and manufacturer social media | Not applicable on the recorded facts | — |
| IFU, label, product specification and evaluation documents | Reviewed | Product specification / 2026-08-21 |
5Store form values
The copy-ready values are repeated here for the saved record. Internal mapping codes are kept in the support record, not mixed into the form instructions.
Apple format
Apple uses a regional Yes/No question.
- United States
- No
- Great Britain
- Yes
- EU / EEA + Northern Ireland
- Yes
Google format
Google uses one Health apps declaration with feature categories rather than separate regional Yes/No answers.
Medical device apps
EU/EEA + Northern Ireland: the additional public medical-device information applies.
Internal answer-mapping record
These are Declaration Desk mapping keys, not legal section numbers and not values to enter in either store.
Apple: APPLE_FORM_ASKS_JURISDICTION_DEVICE_STATUS, US_NOT_A_DEVICE_COMPLETE_RECORD, GB_MEDICAL_DEVICE, EU_MDSW_PRESENT
Google: EU_MDSW_PRESENT, GB_MEDICAL_DEVICE
Internal answer-mapping record
These are Declaration Desk mapping keys, not legal section numbers and not values to enter in either store.
Apple: APPLE_FORM_ASKS_JURISDICTION_DEVICE_STATUS, US_NOT_A_DEVICE_COMPLETE_RECORD, GB_MEDICAL_DEVICE, EU_MDSW_PRESENT
Google: EU_MDSW_PRESENT, GB_MEDICAL_DEVICE
6Product claim wording reviewed
This is the product claim wording used as evidence for the result. It is not finished store-form copy and is not an unfinished customer task.
United States — indications for use
Wording reviewed. Supports prescribing decisions by showing the guidance behind each recommendation so the prescriber can review it independently.
Intended users. Healthcare professionals who prescribe treatment
Boundary: Draft — not FDA-cleared or approved
Great Britain — intended purpose
Wording reviewed. Supports prescribing decisions by showing the guidance behind each recommendation so the prescriber can review it independently.
Intended users. Healthcare professionals who prescribe treatment
EU / EEA + Northern Ireland — intended purpose
Wording reviewed. Supports prescribing decisions by showing the guidance behind each recommendation so the prescriber can review it independently.
Intended users. Healthcare professionals who prescribe treatment
Internal claim-record status
These statuses identify the saved review record. They are not customer tasks or store-form answers.
- United States ·
DRAFT_REQUIRES_JURISDICTION_REVIEW - Great Britain ·
DRAFT_REQUIRES_JURISDICTION_REVIEW - EU / EEA + Northern Ireland ·
DRAFT_REQUIRES_JURISDICTION_REVIEW
Internal claim-record status
These statuses identify the saved review record. They are not customer tasks or store-form answers.
- United States ·
DRAFT_REQUIRES_JURISDICTION_REVIEW - Great Britain ·
DRAFT_REQUIRES_JURISDICTION_REVIEW - EU / EEA + Northern Ireland ·
DRAFT_REQUIRES_JURISDICTION_REVIEW
7Reasoning and legal sources
What this record covers. United States · Great Britain · EU / EEA + Northern Ireland · Layer 1 qualification only
The decision path and the official reference list are preserved separately. A source is grouped with its market below; we do not claim that a particular path line cites one exact source unless that association was recorded.
Prescribing recommendation for a healthcare professional
United States
We checked whether the software function fits a statutory software exclusion and whether any recorded exception brings it back into device regulation.
- Check 1. What kind of item did we assess? → Software functionReason: §520(o)(1) excludes software functions; General Wellness policy can cover other products.
- Check 2. Does one of the US statutory software exclusions in FD&C Act §520(o)(1) apply? → Clinical decision support (CDS)
- Check 3. Does the special blood-software rule apply? → No
- Check 4. Does the recorded patient-risk exception in FD&C Act §513(a)(1)(C) bring the function back under FDA device oversight? → No
- Check 5. Did we identify a current FDA final order under §520(o)(3) that changes this exclusion? → No current FDA final order was identified that changes this exclusion
Official references for this market: S1, S2, S3, S4, S5
Internal path identifiers
US S1→software_functionUS S2→cdsUS S3→NOUS S3→NOUS S3→not_identified_current
Internal path identifiers
US S1→software_functionUS S2→cdsUS S3→NOUS S3→NOUS S3→not_identified_current
Great Britain
We checked whether the software has a medical intended purpose under the UK medical-device definition and whether a separate device relationship changes the route.
- Check 1. Is the assessed item software or another functional digital product? → YesReason: UK MDR 2002 includes software in the device definition.
- Check 2. What medical purpose is claimed for this function? → A disease — detect, predict, prevent, monitor, treat or relieve it
- Check 3. Does the function only predict or estimate future health? → NoReason: MHRA v1.10f distinguishes patient-specific risk from broad population risk.
- Check 4. Is the output a symptom-checker result? → Not a symptom checkerReason: MHRA Appendix 1 distinction.
- Check 5. Does this function perform the recorded medical purpose? → Yes
- Check 6. Is this a clinical calculator? → NoReason: MHRA Appendix 2
- Check 7. Does it analyze information obtained from a human specimen? → No
- Check 8. Does it work with another regulated medical device? → None
Official references for this market: S6, S7
Internal path identifiers
G1→YESG2→A disease — detect, predict, prevent, monitor, treat or relieve itG2a→NOG2b→not_symptom_checkerG2 function check→YESG2c→NOG3→NOG4→none
Internal path identifiers
G1→YESG2→A disease — detect, predict, prevent, monitor, treat or relieve itG2a→NOG2b→not_symptom_checkerG2 function check→YESG2c→NOG3→NOG4→none
EU / EEA + Northern Ireland
We checked whether the function does more than simple storage or communication, acts for an individual person and has its own medical intended purpose.
- Check 1. Does the software process input data and create new output? → YesReason: MDCG section 2
- Check 2. Is it one of the non-medical-purpose products listed in MDR Annex XVI? → No
- Check 3. Does a specific regulated hardware or device relationship apply? → None
- Check 4. Does it do more than store, communicate, search or compress information without changing it? → Yes
- Check 5. Does the function act for the benefit of an individual person? → YesReason: This does not itself establish a medical purpose.
- Check 6. What medical purpose is claimed for this function? → A disease — detect, predict, prevent, monitor, treat or relieve it
- Check 7. Does this function perform the recorded medical purpose? → Yes
- Check 8. Where was the medical-purpose claim recorded? → App-store description or category, Product website, Product specification / evaluation
- Check 9. Does it provide information by examining a human-derived specimen? → No
Official references for this market: S8, S9, S10
Internal path identifiers
Step 1→YESStep 2a→NOStep 2b→noneStep 3→YESStep 4→YESStep 5→A disease — detect, predict, prevent, monitor, treat or relieve itStep 5 function check→YESStep 5 evidence→App-store description or category, Product website, Product specification / evaluationFigure 2-1→NO
Internal path identifiers
Step 1→YESStep 2a→NOStep 2b→noneStep 3→YESStep 4→YESStep 5→A disease — detect, predict, prevent, monitor, treat or relieve itStep 5 function check→YESStep 5 evidence→App-store description or category, Product website, Product specification / evaluationFigure 2-1→NO
Official source documents
| No. | Market | Document / locator |
|---|---|---|
| S1 | United States | 21 U.S.C. 321(h) |
| S2 | United States | 21 U.S.C. 360j(o) |
| S3 | United States | 21 CFR 801.4 |
| S4 | United States | FDA General Wellness: Policy for Low Risk Devices (2026-01-06) |
| S5 | United States | FDA Policy for Device Software Functions and Mobile Medical Applications (2022-09-28) |
| S6 | Great Britain | UK MDR 2002, regulation 2(1) |
| S7 | Great Britain | MHRA Medical device stand-alone software including apps v1.10f (July 2023) |
| S8 | EU / EEA + Northern Ireland | Regulation (EU) 2017/745, Article 2 |
| S9 | EU / EEA + Northern Ireland | Regulation (EU) 2017/746, Article 2(2) |
| S10 | EU / EEA + Northern Ireland | MDCG 2019-11 Rev.1 (June 2025), sections 2, 3 and 7, Figures 1 and 2 |
Internal source aliases
These aliases are Declaration Desk record keys, not legal section numbers and not store-form answers.
- S1
FDCA_DEVICE- S2
FDCA_520O- S3
CFR_INTENDED_USE- S4
FDA_GENERAL_WELLNESS- S5
FDA_DEVICE_SOFTWARE- S6
UK_MDR- S7
MHRA_SOFTWARE- S8
MDR- S9
IVDR- S10
MDCG
Internal source aliases
These aliases are Declaration Desk record keys, not legal section numbers and not store-form answers.
- S1
FDCA_DEVICE- S2
FDCA_520O- S3
CFR_INTENDED_USE- S4
FDA_GENERAL_WELLNESS- S5
FDA_DEVICE_SOFTWARE- S6
UK_MDR- S7
MHRA_SOFTWARE- S8
MDR- S9
IVDR- S10
MDCG
8Is anything still open?
No open item was recorded in the sections that were assessed.
9When should I request a new review?
This record answers for the product exactly as recorded. Any of these makes it out of date:
- A function was added or changed — especially a new result screen, score or recommendation.
- The store wording, category or age-rating answers changed.
- A distribution country or region was added — in particular Northern Ireland (which brings the six public disclosures) or the United States.
- The product started working with another device or test instrument.
- A new claim appeared in advertising, reviews or social media — these are evidence channels.
- You or we confirmed that the Apple or Google form itself changed.