Gap analysis
MDR gap analysis that turns findings into actions
An MDR gap analysis compares a manufacturer's current technical documentation and quality system with the requirements of Regulation (EU) 2017/745 and lists what is missing or insufficient. It is the usual starting point when moving a device from the MDD to the MDR, after a significant change, or before a notified body review. MDRpilot performs a continuous gap analysis from the data in your workspace: missing sections, GSPR rows without evidence, failed test reports, clinical gaps, missing QMS documents and documents flagged by product changes.
Who it is for
- Manufacturers transitioning MDD devices
- Teams taking over a technical file from another owner
- Companies preparing for a notified body technical documentation review
Key capabilities
Section and evidence gaps
Missing technical file sections and GSPR rows without evidence.
Failed test detection
Test reports with a fail verdict add a gap note instead of supporting the requirement.
Clinical gap matrix
Claims and GSPRs without sufficient clinical data.
Change impact
Documents that depend on changed product data are flagged.
QMS gaps
Required procedures that are missing or not approved.
Where MDD-to-MDR gaps usually appear
| Area | Typical gap |
|---|---|
| Requirements | Essential Requirements checklist not converted to Annex I GSPR, including new requirements such as Section 10.4 on substances |
| Classification | Class changed under MDR rules, for example for software or substance-based devices |
| Clinical evaluation | Insufficient clinical data, equivalence that no longer holds under MDR |
| PMS | No PMS plan under Annex III, no PSUR schedule, no PMCF plan |
| Labelling | Missing UDI, new symbols or information required by Annex I Section 23 |
| QMS | Procedures that do not address Article 10(9), PRRC not designated |
Gap analysis as a continuous view
A one-off gap report is out of date as soon as work starts. In MDRpilot gaps are derived from the current state of the workspace, so they shrink as you add evidence and approve documents, and reappear when a product change affects existing content.
How the workflow runs
- 1
Load current state
Add the product and upload existing documents and evidence.
- 2
Review gaps
Use the readiness and module views.
- 3
Plan
Turn gaps into actions with owners.
- 4
Close
Re-check as evidence is added.
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 finds missing or unlinked items. Judging whether existing evidence is scientifically adequate needs qualified reviewers.
- Uploaded legacy documents are analysed automatically but should be checked; poor scans reduce accuracy.
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 gap analysis?
A comparison of current documentation and processes with the requirements of Regulation (EU) 2017/745, resulting in a list of missing or insufficient items.
How long does a gap analysis take in MDRpilot?
It depends on how much existing documentation you upload and link. Gaps are calculated from the workspace as soon as data is entered.
Can MDRpilot analyse our existing MDD file?
You can upload existing documents; they are analysed for standards and verdicts and proposed as evidence. Converting the Essential Requirements checklist into GSPR rows is done in the GSPR module.
Does MDRpilot do the gap analysis for us?
It shows structural gaps automatically. Interpreting them and deciding the remediation remains with your team or consultant.
Does a change to the device trigger a new gap analysis?
Changes to impact-relevant fields flag the dependent documents, which then appear as items to review.
Related workflows
- 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
- 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
- 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
- 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
Guides and resources
- MDR Gap Analysis GuideHow to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.Read more
- What Is GSPR Compliance?What the General Safety and Performance Requirements are, how Annex I is organised, how to document GSPR compliance and the mistakes reviewers find most often.Read more
- MDR Audit Preparation ChecklistA practical checklist for notified body QMS audits and technical documentation reviews under the EU MDR, including unannounced audits, records to have ready and how to rehearse.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2023/607 amending the MDR transitional provisions — EUR-Lex, Publications Office of the European Union.
- MDCG 2020-6 Sufficient clinical evidence for legacy devices — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
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
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