- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745
Evaluation criteria
| Criterion | What good looks like |
|---|---|
| Product-centred data | Device description, class and standards entered once and reused in every document |
| GSPR traceability | Each Annex I row links to standards and specific controlled evidence |
| Risk traceability | Risk controls link to verification evidence and to GSPR rows |
| Evidence handling | Uploads are analysed, links proposed, and a person confirms them; failed results are not used as support |
| Change impact | Changes to key product data flag the documents that depend on them |
| Clinical and PMS | CEP, CER, PMCF and PSUR or PMS report connected to the same product record |
| Document control | Review, approval, release and history; approved documents stay effective |
| AI controls | Templates, confirmed facts, explicit unknowns, review, audit log, opt-out |
| Exports | Formats your notified body accepts, such as DOCX, PDF, XLSX and ZIP |
| Data protection | Tenant isolation, roles, 2FA, clear sub-processor information, deletion |
| Team fit | Pricing and setup effort proportionate to the number of devices and users |
Questions to ask any vendor
- Show me how a failed test report is handled.
- Change the device class in the demo: what happens to the PSUR schedule and the technical file?
- Where does the AI get company facts from, and what happens if one is missing?
- Which AI providers process our data, and can we turn that off?
- How do we get all our data out if we leave?
- Which regulations are in scope and which are not?
A simple scoring template
Weight each criterion from 1 to 3 by importance for your situation, score each tool from 0 to 3 based on a live demonstration with your own device, and multiply. Score only what you have seen working, not roadmap items. Keep the notes; they are useful when the decision is reviewed later.
MDRpilot against these criteria
- Product-centred: yes, one product record feeds all modules
- GSPR and risk traceability: yes, with evidence links that require confirmation
- Failed tests: not linked as evidence; a gap note is added
- Change impact: dependent documents flagged when class, sterilisation, intended purpose and similar fields change
- Clinical and PMS: CEP, CER, PMCF plan and survey, PSUR or PMS report by class
- Document control: reviewer, approver and release steps with history
- AI controls: locked templates, fact card, [TO BE CONFIRMED], activity log, workspace opt-out
- Exports: DOCX, PDF, XLSX, ZIP and UDI device XML
- Limits: EU MDR focus, no IVDR, no EUDAMED submission, no multi-market registration tracking, no validated computer system package
About this comparison
This framework intentionally does not score named competitors, because their features change and we have not independently verified them. If you want a side-by-side, use the questions above in live demonstrations. The page on evaluating MDR software provides the same framework in a shorter format.
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes — International Organization for Standardization.
- ISO 14971:2019 Medical devices — Application of risk management to medical devices — International Organization for Standardization.
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.