Regulatory affairs
Regulatory affairs software for medical device teams
Regulatory affairs software supports the people who decide and document how a device reaches and stays on the market: classification, conformity assessment route, technical documentation, labelling, UDI and registration, and communication with notified bodies. In MDRpilot the regulatory affairs role works on the same product record as quality and engineering: it documents the Annex VIII classification rationale, owns the technical file structure, prepares UDI device data for EUDAMED, confirms the company's own SRN, and translates documents into the languages of the target markets.
Who it is for
- Regulatory affairs managers and specialists
- PRRCs in small and medium-sized companies
- Regulatory consultants
Key capabilities
Regulatory affairs role
A dedicated company role alongside owner, quality manager, consultant and viewer.
UDI and EUDAMED preparation
UDI device data XML export for manual EUDAMED use; MDRpilot does not submit to EUDAMED.
Own SRN confirmation
Look up the SRN you enter for your own company; MDRpilot does not search or list other actors.
Document translator
Translate regulatory documents with medical terminology handling for review.
Regulatory affairs tasks and where they live
| Task | In MDRpilot |
|---|---|
| Classification and rationale | Annex VIII assistant on the product |
| Conformity assessment planning | Device class and target markets drive which documents are required |
| Technical file ownership | Section status, review and approval |
| UDI | Basic UDI-DI and UDI data on the product, UDI device XML export, DataMatrix generation |
| Actor registration | Look up and confirm your own company's SRN |
| Translations | Document translator across seven languages |
| Notified body readiness | Readiness score, simulator and exports |
Working with quality, not in parallel
Regulatory affairs depends on evidence produced by engineering and records produced by quality. When those live in separate tools, regulatory affairs becomes a chasing exercise. In MDRpilot the regulatory affairs role sees evidence as it is uploaded, CAPAs as they are opened and documents as they are approved, and receives flags when product data changes.
How the workflow runs
- 1
Classify
Document class and rule.
- 2
Plan
Define the documentation required for the class and markets.
- 3
Coordinate
Track sections, evidence and approvals.
- 4
Prepare submission
Export the file and UDI data.
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
- MDRpilot does not submit data to EUDAMED or to national authorities.
- Registration in markets outside the EU is not managed.
- Translations are drafts and must be reviewed by a qualified translator or native-speaking expert.
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
What does a medical device regulatory affairs team do?
It determines and documents the regulatory strategy for each device: classification, conformity assessment route, technical documentation, labelling, UDI and registration, and it manages communication with notified bodies and authorities.
Can MDRpilot submit to EUDAMED?
No. It prepares UDI device data XML for manual use and helps you confirm your own SRN.
Does MDRpilot help with classification?
Yes. The Annex VIII assistant suggests a class and rule from your answers and stores the rationale. Your team confirms the class.
Which languages can documents be translated into?
English, Turkish, German, French, Spanish, Italian and Dutch.
Can regulatory affairs see changes made by quality or engineering?
Yes. All roles work on the same product record, and the activity log shows who changed what.
Related workflows
- 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
- Software for the obligations in Regulation (EU) 2017/745Software support for the obligations in Regulation (EU) 2017/745: Article 10 manufacturer duties, Annex I GSPR, Annex II/III documentation, clinical evaluation and PMS.Read more
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- MDR technical documentation under Annex II and Annex IIIWhat MDR Annex II and Annex III require in the technical documentation, section by section, and how each section is handled in MDRpilot.Read more
- AI for medical device regulatory work, with guardrailsHow AI can support medical device regulatory affairs without inventing facts: controlled templates, confirmed company facts, human approval and a workspace-level opt-out.Read more
Guides and resources
- 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
- MDR Annex II and Annex III ExplainedSection-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.Read more
- MDR Software for Small and Medium-Sized Medical Device ManufacturersWhat SMEs need from MDR software: small teams covering many roles, PRRC at disposal, limited budgets, consultant collaboration and a fast path from legacy files to MDR.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- EUDAMED overview — European Commission.
- MDCG 2021-24 Guidance on classification of medical devices — Medical Device Coordination Group. Listed under classification.
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.