Draft in-house
Pro
299 EUR/ month
For a manufacturer drafting vigilance narratives in-house.
- Unlimited narratives
- Eudamed field mapping
- PDF/XML export
Vigilance Narrator · EU MDR 2017/745
From incident to a submittable MIR narrative in 20 minutes
A short incident note becomes a Manufacturer Incident Report draft: event type, seriousness, expected or unexpected, causality, device identity, patient impact, and CAPA. Facts that are not in the note stay marked incomplete.
- Written against MDCG 2023-3 and the MIR field structure
- The draft is in English. The note can be Danish, German, or English
- From MiBB Regulatory, founded by a former Notified Body assessor
Drafts for a PRRC to review. No report is submitted from this page.
2days
Public health threat
A serious public health threat is reported within two days. Death or a serious deterioration is ten days. Every other serious incident is fifteen.
285EUR
Per vigilance report a notified body reviews
285 EUR each time a notified body reviews a vigilance report. The fee is the small part. The expensive part is a narrative that does not answer the question.
600,000EUR+
Annual cost for a large manufacturer
600,000 EUR or more a year in vigilance cost at a large manufacturer, before anyone counts a report that went out late.
Live demo
Type a fictional incident. Read the draft.
The result is labelled as a demo. If the model key is absent, a local fallback writes the draft and says so on the page. It will not invent a batch number or a diagnosis.
Demo. Fictional incidents only. Nothing on this page is filed with a competent authority.
Pricing
Pro for the draft. Business for the PRRC.
Pro is 299 EUR per month: unlimited narratives, Eudamed field mapping, and PDF/XML export. Business is 999 EUR per month: everything in Pro, plus batch upload, an audit trail, and a dedicated PRRC review queue.
PRRC in the loop
Business
999 EUR/ month
Everything in Pro, with a human PRRC in the loop.
- Everything in Pro
- Batch upload
- Audit trail
- Dedicated PRRC review queue
FAQ
What a vigilance draft can and cannot do.
Straight answers, including the one manufacturers ask first.
Can an AI really write something that holds up in an audit?
Yes, with a human PRRC in the loop, which is exactly why the Business plan exists.
Is the draft a submitted Manufacturer Incident Report?
No. It is a field-by-field draft aligned with the MIR structure and MDCG 2023-3. The Person Responsible for Regulatory Compliance decides what is sent to the competent authority. Nothing in this app files a report.
What happens when a mandatory field is not in the description?
The field is marked incomplete. The draft does not invent a batch number, a diagnosis, or an outcome that the text does not contain.
Which languages can the incident be written in?
Danish, German, or English. The draft is written in English. Device names, batch numbers, and serial numbers stay as written.
What are the reporting deadlines?
Two days for a serious public health threat, ten days for death or a serious deterioration in state of health, and fifteen days for every other serious incident. The deadline does not change with the language of the note.
Do I need an account to use the checker?
No. The checker asks for an email before it shows the seriousness, the deadline, and whether reporting is required. The full narrative is part of the paid plans.