AI and regulatory
AI for medical device regulatory work, with guardrails
AI in medical device regulatory work means using language models to draft, summarise, translate and cross-check regulatory documents. The risk is that a model writes plausible but untrue statements, such as a retention period, an authority or a test result, into a controlled document. MDRpilot uses AI as an assistant inside a regulatory workspace: templates lock document headings, company facts come from the profile, unconfirmed points are marked [TO BE CONFIRMED], and every draft must be reviewed and approved by a person. A company owner can switch external AI off for the whole workspace.
Who it is for
- Regulatory teams evaluating AI tools
- Quality managers who must control AI-generated content
- Data protection officers reviewing AI processing
Key capabilities
Controlled templates
Headings and preamble are fixed; AI writes within them.
Fact card
Every draft lists the company facts it used and the facts still to confirm.
Human approval
Drafts go through review and approval before they are effective.
Workspace opt-out
Owners can disable external AI processing in Settings.
Where AI helps and where it should not decide
| Task | Role of AI in MDRpilot |
|---|---|
| Drafting procedures and sections | Fills section bodies inside locked templates using confirmed facts |
| Reading test reports | Extracts the standard and pass or fail verdict and proposes links; a user confirms |
| Literature screening support | Helps structure search and summaries; evaluators appraise the papers |
| Translation | Translates documents with medical terminology handling for review |
| Classification | Not AI: the Annex VIII assistant is rule-based and shows its reasoning |
| Approval and release | Never AI: always a named user with the right role |
Guardrails that are built in
- Facts used and facts still to confirm are shown next to every procedure draft
- In procedure drafts, statements such as retention years or notified body numbers that are not in your profile are removed from AI output
- AI generation and approvals are recorded in the activity log
- Provider API keys stay on the server and never reach the browser
- External AI can be turned off per company; non-AI workflows keep working
The EU AI Act and your own devices
Regulation (EU) 2024/1689, the AI Act, treats AI systems that are medical devices, or safety components of them, requiring notified body assessment under MDR as high-risk AI systems, with obligations applying from 2 August 2027. That concerns AI inside your device. MDRpilot is a documentation tool used by manufacturers, not a medical device and not part of one.
How the workflow runs
- 1
Confirm facts
Complete the company profile.
- 2
Answer specifics
Answer the questions for the procedure or section.
- 3
Draft
Generate within the template.
- 4
Review
Check, edit and approve.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- AI can still misread or misphrase; review is mandatory, not optional.
- When external AI is used, relevant excerpts are processed by the configured providers, for example OpenAI or Anthropic, under the terms described in the privacy policy.
- AI does not replace qualified clinical evaluators, risk managers or the PRRC.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
Does MDRpilot use AI to make regulatory decisions?
No. AI drafts and proposes. Classification is rule-based with visible reasoning, and approvals are always made by people.
Can we turn AI off?
Yes. A company owner can disable external AI processing for the workspace in Settings.
Is our data used to train AI models?
Excerpts are sent to the configured providers only to generate the output you request. Where providers offer contractual options, MDRpilot configures them not to use customer data for training public models, as described in the privacy policy.
What stops AI from inventing a retention period or authority?
Those facts come from your profile. If they are missing, the procedure draft shows [TO BE CONFIRMED], and unconfirmed claims of that type are removed from the AI output.
Is MDRpilot itself subject to the AI Act as a high-risk system?
MDRpilot is not a medical device and is not a safety component of one. The AI Act's high-risk rules for medical devices concern AI inside regulated devices. For your own assessment, consult the regulation text.
Related workflows
- MDR software that keeps your technical file, evidence and quality records connectedWhat MDR software does, who needs it and how MDRpilot connects technical documentation, GSPR, risk, clinical, PMS and QMS work in one regulatory workspace.Read more
- ISO 13485 software for quality manuals, procedures and controlled recordsBuild and run ISO 13485:2016 documentation: quality manual wizard, SOPs, forms, document control with review and approval, and a controlled document register.Read more
- Security and data handlingHow MDRpilot isolates company data, authenticates users, handles AI providers and deletes data.Read more
- Regulatory affairs software for medical device teamsTools for medical device regulatory affairs teams: classification rationale, technical file ownership, UDI data, translations and notified body readiness.Read more
- Medical device regulatory software: what the category coversHow medical device regulatory software differs from eQMS, document management and spreadsheets, and where an AI-assisted regulatory workspace like MDRpilot fits.Read more
Guides and resources
- AI in Medical Device Regulatory AffairsWhere AI genuinely helps regulatory affairs teams, where it creates risk, how to control AI-generated content in a QMS and what the EU AI Act does and does not cover.Read more
- MDR Technical Documentation Software ComparisonA neutral framework for comparing MDR technical documentation software: criteria, questions to ask vendors, a scoring template and what MDRpilot does and does not offer.Read more
- What Is EU MDR 2017/745?A plain explanation of the EU Medical Device Regulation 2017/745: scope, key dates, classification, conformity assessment, economic operators and what changed from the MDD.Read more
References
- Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (AI Act) — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- MDCG 2019-11 Qualification and classification of software (MDR and IVDR) — Medical Device Coordination Group. Listed under medical device software.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.