Illustrative case study
Ophthalmic Device Technical Documentation: An Illustrative Case Study
Illustrative scenario: a sterile, EO-sterilised ophthalmic device moves from scattered evidence to a traceable MDR technical file, with gaps in biocompatibility, EO residuals, sterilisation, PMS/PMCF and traceability.
Demo scenario. This is a demonstration scenario built on a fictional manufacturer and device. It shows how the MDRpilot workflow surfaces and closes typical gaps. It does not describe a real customer, and no outcome figures are claimed.
The device
A fictional single-use, sterile ophthalmic surgical instrument, sterilised with ethylene oxide (EO), in transient contact with the eye, intended for use by ophthalmic surgeons. The manufacturer has assessed it as Class IIa under Annex VIII Rule 6; the class is confirmed by the manufacturer, not by MDRpilot.
1. Problem
- Test reports stored in several folders, with file names that do not identify the standard or edition
- Biocompatibility evidence based on an older ISO 10993-1 assessment, without a documented biological evaluation for the current materials
- EO residual testing (ISO 10993-7) referenced in the GSPR checklist but the report not located
- Sterilisation validation (ISO 11135) completed, but the report not linked to the GSPR rows on sterility
- PMS plan generic across product lines; no PMCF plan or justification
- Lot-level traceability from complaint records to production records incomplete
2. Workflow in MDRpilot
- The product record is created with intended purpose, Class IIa rationale, sterilisation method EO, and applied standards.
- The GSPR checklist is worked through; Sections 10 (chemical, physical and biological properties), 11 (infection and microbial contamination) and 23 (information supplied) are marked applicable with methods and standards.
- Existing test reports are uploaded. MDRpilot reads each for its standard and verdict and proposes links to GSPR rows and risk controls.
- The regulatory specialist confirms or rejects each proposal.
- The risk file is reviewed: controls for residual EO and loss of sterility are linked to the verification evidence.
- The PMS module is used to write a device-specific PMS plan and a PMCF plan.
3. Evidence
- Sterilisation validation report following ISO 11135: verdict pass, proposed for the sterility GSPR rows and the sterility-related risk control, confirmed
- Biological evaluation plan and cytotoxicity, sensitisation and irritation reports following the ISO 10993 series: cytotoxicity pass; the biological evaluation report itself missing
- EO residual report following ISO 10993-7: not found during upload, so no evidence is proposed for that row
- Packaging validation following ISO 11607: verdict pass, linked to sterile barrier rows
4. Gaps found
| Gap | Requirement |
|---|---|
| No biological evaluation report covering the current materials | Annex I Section 10.4 and ISO 10993-1 biological evaluation |
| EO residual evidence missing | Annex I Section 10.4 and ISO 10993-7 |
| No device-specific PMS plan indicators | Annex III Section 1.1 |
| No PMCF plan or justification | Annex XIV Part B |
| Incomplete link from complaints to production lots | ISO 13485 clause 7.5.9 and MDR Article 10(9) |
5. Resolution
- A biological evaluation report is commissioned from the test laboratory and its GSPR rows remain open until it is uploaded and confirmed.
- The EO residual test is repeated on current production lots; the passing report is uploaded and confirmed against the substance and residual rows.
- The PMS plan is rewritten with device-specific indicators, such as complaint rate per lot and reported corneal irritation, and threshold values.
- A PMCF plan with a user survey is created from the clinical gap matrix.
- The complaint form is updated to require the lot number, and a CAPA is opened for the traceability gap.
6. Audit readiness
- All applicable Section 10, 11 and 23 GSPR rows have a confirmed evidence link or an open action with an owner
- Every sterility and EO-related risk control has verification evidence
- The readiness view lists the remaining open items instead of an unknown number of missing files
- The technical file and GSPR checklist export together with consistent references
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
- 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
- PMS and PMCF software that feeds back into risk and clinical evaluationPost-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.Read more
- 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
- 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
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.