Illustrative case study
MDR Technical File Gap Analysis: An Illustrative Case Study
Illustrative scenario: a legacy MDD Class IIb device file is analysed against MDR Annexes I, II, III and XIV, and the gaps are turned into a tracked plan.
Demo scenario. This is a demonstration scenario on a fictional legacy device. It illustrates the gap analysis workflow in MDRpilot. It does not describe a real customer or a real notified body decision.
The device
A fictional non-implantable Class IIb active device previously certified under the MDD, with an Essential Requirements checklist, a risk file aligned with the 2012 EN edition of ISO 14971 and a clinical evaluation based mainly on literature for an equivalent device.
1. Problem
- Essential Requirements checklist not converted to Annex I GSPRs
- Risk management file not updated to ISO 14971:2019 terminology and process
- Equivalence claim documented in a paragraph, without a characteristic-by-characteristic comparison
- No PSUR schedule; post-market data summarised informally once a year
- Several design changes made since certification without documented impact assessment
2. Workflow in MDRpilot
- The legacy device is added with its current description and class, and the existing documents are uploaded as files.
- The GSPR module is used to rebuild the checklist on Annex I and record which legacy evidence still applies.
- Test reports are analysed and proposed as evidence where standard and verdict match; outdated editions are noted.
- The clinical module is used to lay out the equivalence comparison and the clinical gap matrix.
- The PMS module sets the PSUR schedule for Class IIb.
- Product changes are recorded; change impact flags show which documents depend on the changed fields.
3. Evidence
- Electrical safety and EMC reports to current IEC 60601 editions: pass, linked to the relevant rows
- Software verification report: present but based on an older lifecycle process; noted as a gap
- Literature on the equivalent device: present, but technical characteristics of the equivalent device are not documented
4. Gaps found
| Gap | Requirement |
|---|---|
| GSPR checklist missing for Annex I | Annex II Section 4 |
| Risk file not aligned with ISO 14971:2019 and Annex I Sections 2–4 | Annex I Chapter I |
| Equivalence not demonstrated characteristic by characteristic | Annex XIV Part A Section 3 and MDCG 2020-5 |
| No PSUR | Article 86 |
| Design changes without documented impact assessment | Article 10(9) and ISO 13485 clause 7.3.9 |
5. Resolution
- Each gap is assigned an owner and due date and tracked to closure.
- The GSPR checklist is completed and linked to existing and new evidence.
- The risk file is revised to the 2019 process, with verification evidence for each control.
- The equivalence table is completed; where data on the equivalent device cannot be obtained, the clinical strategy is revised and PMCF planned.
- A first PSUR is prepared, and change records are documented for past design changes.
6. Audit readiness
- The gap list shrinks as evidence is confirmed and documents are approved
- The notified body receives a file with consistent device description, GSPR, risk and clinical sections
- Remaining open items are known and justified rather than discovered during review
Where this fits in the workflow
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.
Related workflows and guides
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
- 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
- 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
- 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
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.