- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745 · Regulation (EU) 2024/1689
Tasks where AI is useful
| Task | Benefit and control needed |
|---|---|
| Drafting procedures and report sections | Removes blank-page work and keeps structure consistent; requires confirmed inputs and fixed templates |
| Extracting data from test reports | Finds the standard, sample size and verdict quickly; requires a person to confirm each extracted link |
| Literature screening support | Helps sort large result sets; requires evaluators to appraise full texts |
| Translation | Fast first drafts in several languages; requires review by a qualified native speaker |
| Consistency checks | Spots differing wording across documents; requires a person to decide which text is correct |
Where AI creates risk
- Invented specifics: retention periods, authority names, notified body numbers, test results
- Generic text that does not match how the company actually works
- Silent changes in wording of the intended purpose
- Confidential design data sent to external services without a basis
- Over-reliance: reviewers approving drafts they did not read
Controlling AI output in a QMS
Treat AI as a tool within document control. Define in a procedure where AI may be used, which inputs it may receive, how drafts are reviewed and how AI use is recorded. Keep templates with locked headings so structure is not changed, and supply the model only with facts that are confirmed in a controlled source such as the company profile. Where a fact is unknown, the draft should say so explicitly.
The EU AI Act in context
Regulation (EU) 2024/1689 classifies as high-risk those AI systems that are products, or safety components of products, covered by Union harmonisation legislation such as the MDR when that product requires third-party conformity assessment. For medical devices this means AI software that is itself a device or part of one; the obligations apply from 2 August 2027. Tools used by manufacturers to write documentation are a different situation and should be assessed on their own facts.
How MDRpilot applies these principles
In MDRpilot AI drafts section bodies inside templates with locked headings; company facts come from the profile; procedure-specific questions are asked before generation; unknowns appear as [TO BE CONFIRMED]; in procedure drafts, unconfirmed retention years and notified body numbers are removed from AI output; drafts go through review and approval; AI generation is recorded in the activity log; provider keys stay on the server; and a company owner can turn off external AI for the workspace. Classification uses a rule-based assistant, not AI.
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.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
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.