Is Practice Software a Medical Device? (MDR)

Last updated: 29 September 2026

1. Regulatory classification

Brigid's launch intended purpose is administrative practice-management. It is not intended or authorised for a medical purpose. DJG Media Limited (trading as Brigid), CRO No. 762838 does not hold or claim an EU MDR CE mark for the current product. The manufacturer recorded an administrative-purpose determination on 10 September 2026. That record does not by itself cover a changed feature set or the subsequent patient-app release. The release assessment must address the actual functions and claims; this page is not regulatory approval.

Software qualification is assessed under MDR Article 2(1) and the current MDCG 2019-11 revision 1 guidance. A qualification query to the Health Products Regulatory Authority was prepared but not submitted; no HPRA position is claimed. No declaration of conformity under any MDR class has been made. The accountable director has declared an administrative intended purpose for each enabled route (25, 30 and 31 August 2026); those declarations are the manufacturer's position, not an HPRA approval.

Provider: DJG Media Limited (trading as Brigid), CRO No. 762838, Coliemore House, Coliemore Road, Dalkey, Dublin, Ireland
Product: Brigid, within the Brigid product family
Current intended purpose: clinic administration, records workflow, booking, billing, task management, approved templates and staff-authored documents
Current evidence: no notified body, Basic UDI-DI, UDI-DI or medical-device CE mark is held or claimed; formal qualification remains a release record

2. Intended use

Brigid is intended for clinic staff to organise administrative work. It can:

Store, retrieve, and organise clinic records and documents
Support appointment scheduling, billing, reminders, and administrative task queues
Transcribe clinician dictation and format clinician-supplied information
Prepare administrative drafts for a person to review before use
Support patient access, messaging, and consent administration

Administrative Generative AI is enabled only for routes whose administrative intended purpose has been declared by the accountable director and is pinned by automated boundary tests. Every such output is shown to staff as AI-generated and must be verified by an authorised person before use. Patient consent cannot enable any route. Generative AI that makes a clinical judgement, and all patient-facing Generative AI, is disabled.

AI-assisted functions currently enabled, each declared administrative: (a) a prose restatement of information already recorded in a patient's chart, shown to the treating clinician before a consultation and on request from the in-product assistant — it adds no opinion, ranking, risk grade or recommendation, and its qualification under MDR Article 2(1) requires the release assessment described in section 1. The separate notes-enrichment route that writes into a patient's free-text record is disabled; (b) labelling and one-line summaries of the practice's own correspondence, staff to-dos raised from it, and reply drafts limited to logistics; (c) identifying which patient an emailed document belongs to and filing it, without interpreting the document clinically; (d) a setup assistant used during clinic onboarding that processes no patient data; (e) the note assistant, declared on 28 September 2026: it writes down what a clinician said, and tidies what they wrote, in a note or letter the clinician then reads and signs. It drafts from the consultation transcript, the clinician's own words and, when asked, what is already in the chart. Its instructions, held on the server where the user cannot edit them, forbid a diagnosis, differential, urgency or severity grading, triage, clinical coding, and any recommendation the clinician did not already make. The draft is labelled as drafted by AI and is not the record until the clinician signs it. Disabled: symptom triage, differential diagnosis, result interpretation or urgency grading, risk scoring, dosing, and all patient-facing Generative AI.

3. Excluded clinical purposes

Brigid is not intended to diagnose, triage, monitor, predict prognosis, recommend treatment, interpret a clinical finding, calculate clinical risk, prescribe, or replace professional judgement. It must not be used in emergencies or as the basis for a diagnosis or treatment decision.

If a workflow appears to provide clinical decision support, do not rely on it. Stop that workflow and contact support@askbrigid.com.

4. EU AI Act transparency

EU AI Act Article 50 (transparency) has applied since 2 August 2026. Staff are told when they are interacting with an AI system — the in-product assistant identifies itself as AI — and every AI-generated output shown to staff is labelled as generated before review (Article 50(1) and 50(2)). Images generated by the platform carry a machine-readable watermark; machine-readable marking of exported documents is being completed within the transition period ending 2 December 2026. Brigid makes no high-risk classification or conformity-assessment claim under the AI Act; the system inventory, provider/deployer role analysis and risk classification are maintained as release records. Patient-facing Generative AI, and Generative AI that diagnoses, triages or recommends, remains disabled.

5. Human review and action controls

Every permitted administrative AI output must be checked by an authorised person before it is used. The platform applies confirmation boundaries to consequential actions:

Drafts are not represented as sent, signed, prescribed, filed, or completed before the relevant server-confirmed action occurs.
Role and permission checks still apply when Brigid prepares or executes an administrative action.
Users can stop, reject, or park work that needs review.

Administrative Generative AI runs only on routes with a declared administrative intended purpose and cannot be enabled by patient consent. Patient-facing Generative AI, and Generative AI that diagnoses, triages or recommends, remains disabled.

6. Audit, privacy, and change control

Each enabled administrative AI route carries a purpose classification, access control, production audit evidence, incident response and model-change records; any further route requires the same before it is enabled. Consent is not a substitute for an allowed purpose or lawful basis.

AI activity records capture operational metadata such as feature, model, timing, and review state without creating a separate MDR technical-file retention claim.
Platform and clinical audit logs follow the controller-approved, record-class retention schedule; no universal period is asserted.
Material purpose changes are reviewed before release. A future medical purpose would require a fresh regulatory assessment before that use is offered.

7. Status updates

We will update this statement before any material change to the product's intended purpose or regulatory status. For qualification enquiries, contact legal@askbrigid.com.

8. Frequently asked questions

Is practice management software a medical device?

Not automatically. Under MDR Article 2(1) and MDCG 2019-11 (the European Commission guidance on qualification and classification of software), administrative software — scheduling, billing, records storage, templates, staff-authored documents — falls outside the medical-device definition when it does not process data to support a clinical decision. Software becomes a medical device when its intended purpose, as stated by the manufacturer, includes diagnosis, monitoring, prediction, prognosis or treatment.

What is Brigid's intended purpose?

Administrative practice-management: clinic administration, records workflow, booking, billing, task management, approved templates and staff-authored documents, as declared in section 1 above. Brigid does not diagnose, triage, monitor, predict prognosis, recommend treatment, interpret a clinical finding, calculate clinical risk or prescribe.

Does dictation or the administrative assistant change that?

No. Dictation transcribes speech to text for the clinician to review; it does not analyse or interpret clinical content. Administrative Generative AI is limited to the declared routes in section 2 (drafting the note or letter the clinician recorded or dictated, prose restatement of information already in the chart, correspondence labelling, document filing, onboarding) — none of it diagnoses, scores risk or recommends care.

Does Ask Brigid hold a CE mark?

No. No notified body, Basic UDI-DI, UDI-DI or medical-device CE mark is held or claimed. Formal qualification remains a release record, and a future change to intended purpose or feature set would require a fresh assessment before that use is offered.

Source guidance: MDCG 2019-11 Rev.1 — Guidance on Qualification and Classification of Software (European Commission).

Is Practice Management Software a Medical Device? (MDR)