Technical file
Technical file software for MDR devices
Technical file software helps a manufacturer assemble and maintain the technical documentation required by MDR Annex II and Annex III for each device or device family. In MDRpilot every product has its own technical file with sections for device description, information supplied by the manufacturer, design and manufacturing, GSPR, benefit-risk and risk management, verification and validation, and post-market surveillance. Each section shows whether it is missing, in draft or approved, and can hold drafts, edits and evidence files.
Who it is for
- Regulatory teams assembling a first MDR technical file
- Manufacturers maintaining several device families
- Consultants preparing files for notified body submission
Key capabilities
Annex II and III sections
A fixed structure per product with missing, draft, in review and approved status.
Drafts from product data
AI drafts a section from the device description, standards and evidence you have entered; you edit and approve.
Evidence per section
Attach test reports, certificates, labels and other files to the section they support.
Review and approval
Reviewer, approver and release steps with an audit log of who changed what and when.
IFU and labelling
Draft the IFU from product data, structured around MDR Annex I Section 23.
From scattered folders to a structured file
Most technical files start as a folder tree that mirrors Annex II. That works until the first change: a new sterilisation supplier, an updated standard or an extended indication. MDRpilot keeps the structure, but the content is drawn from the product record, so the device description, classification rationale and applied standards are the same wherever they appear.
Section status gives a fast answer to the question every reviewer asks first: what is still missing?
Exports that match how files are submitted
- Technical file as DOCX and as a full ZIP package
- GSPR checklist and risk file as XLSX
- IFU as DOCX and labels as PDF
- PMS and PMCF documents as DOCX
- UDI device data as XML for manual EUDAMED preparation
How the workflow runs
- 1
Describe the device
Intended purpose, variants, accessories, class and sterilisation.
- 2
Fill the sections
Draft or write each Annex II section and attach evidence.
- 3
Cross-check
Use the GSPR and risk modules to confirm every claim has support.
- 4
Approve
Route sections through review and approval.
- 5
Export
Generate the submission package in the format your notified body expects.
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 hold design history it has not been given; design and verification evidence must be uploaded.
- Formatting of exports follows MDRpilot templates; some notified bodies have their own submission formats.
- AI drafts are starting points and must be checked against your evidence.
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 is an MDR technical file?
It is the technical documentation described in MDR Annex II and Annex III. It shows how a device meets the General Safety and Performance Requirements and how its post-market surveillance is organised.
Can MDRpilot generate a technical file?
It drafts the sections from your product data and evidence and exports them. It cannot create test results or clinical data, and the drafts must be reviewed and approved by your team.
Is one technical file per device enough for device families?
A technical file can cover a device and its variants when they share the same intended purpose and design basis. MDRpilot stores variants in the product description; how you group devices is your regulatory decision.
Which export formats are available?
DOCX, PDF, XLSX and ZIP depending on the document, plus XML for UDI device data.
Can several people work on the same file?
Yes. Team members are invited with roles such as owner, quality manager, regulatory affairs, consultant or viewer, and changes are recorded in the activity log.
Related workflows
- 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
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- Clinical evaluation software for the CEP, literature and CERPlan and document MDR clinical evaluation: CEP, literature search in PubMed and Europe PMC, equivalence, clinical gap matrix and CER with review and approval.Read more
- Audit readiness for MDR and ISO 13485 auditsPrepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.Read more
Guides and resources
- How to Build an MDR Technical FileA practical sequence for building an MDR technical file: intended purpose, classification, GSPR, risk, verification, clinical evaluation, labelling, PMS and final review.Read more
- EU MDR Technical Documentation: Complete GuideWhat EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.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
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
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.