# Fictional worked examples: MDR evidence references

Conformo Editorial Team · 2026-10-06

All devices, identifiers, revisions and observations are fictional. No example records a completed specialist review. Use the separate Evidence register sheet in the Excel workbook for your own device.

## 1. Device identity and purpose

- MDR reference: Annex II 1.1(a)
- Applicability: Applicable
- Rationale: The fictional device has a defined medical purpose and intended users.
- Document / revision: EX-DD-001, revision A
- Evidence location: Section 1.2, intended purpose and users
- Method / comparison: Cross-document comparison with EX-IFU-001 revision B, section 2
- Evidence status: Linked
- Review status: Review pending
- Owner: Technical-file owner (fictional role)
- Next action: Device description says trained healthcare staff; IFU says home users. Resolve the scope difference before closing this item.
- Reviewer / review date: blank; no completed review is claimed.

## 2. Classification rationale

- MDR reference: Annex II 1.1(f)
- Applicability: Applicable
- Rationale: A classification rationale is needed for the fictional device's regulatory scope.
- Document / revision: No reference entered
- Evidence location: Not recorded
- Method / comparison: Locate the classification rationale for specialist review
- Evidence status: Not linked
- Review status: Review pending
- Owner: Regulatory lead (fictional role)
- Next action: No classification reference is recorded in this example. Locate the full-file record; do not infer a risk class or whole-file absence.
- Reviewer / review date: blank; no completed review is claimed.

## 3. Software verification and validation

- MDR reference: Annex II 6.1(b)
- Applicability: Applicable
- Rationale: The fictional device includes software release 2.0.
- Document / revision: EX-SWV-001, revision A
- Evidence location: Section 3, tested build 1.8
- Method / comparison: Compare tested build and released configuration
- Evidence status: Linked
- Review status: Changes requested
- Owner: Software lead (fictional role)
- Next action: The located report names build 1.8; the device description names release 2.0. Request release-specific evidence or a justified bridging assessment.
- Reviewer / review date: blank; no completed review is claimed.

## 4. Sterility and microbial condition

- MDR reference: Annex II 6.2(e)
- Applicability: Not applicable
- Rationale: Fictional design scope: supplied non-sterile, no defined microbial condition, no sterilisation claim. Decision still awaits specialist review.
- Document / revision: EX-DD-001, revision A
- Evidence location: Section 2.4, supply condition
- Method / comparison: Compare supply-condition statement with EX-LBL-001 revision A
- Evidence status: Linked
- Review status: Review pending
- Owner: Regulatory lead (fictional role)
- Next action: Confirm the scope against labeling and the complete documentation. This example does not waive other microbial-safety requirements.
- Reviewer / review date: blank; no completed review is claimed.

## 5. Indicators and thresholds

- MDR reference: Annex III 1(b)
- Applicability: Applicable
- Rationale: The fictional PMS plan needs defined reassessment triggers.
- Document / revision: EX-PMS-001, revision A
- Evidence location: Section 5, placeholder for triggers
- Method / comparison: Locate the approved indicator and threshold definition
- Evidence status: Linked
- Review status: Changes requested
- Owner: PMS owner (fictional role)
- Next action: The example section says to define triggers but gives none. Ask the responsible specialists for justified indicators and thresholds.
- Reviewer / review date: blank; no completed review is claimed.

## 6. PMS report or PSUR

- MDR reference: Annex III 2
- Applicability: To assess
- Rationale: Classification and reporting approach have not been established in the fictional example.
- Document / revision: EX-PMSR-001, revision A
- Evidence location: Cover, reporting period 2025
- Method / comparison: Check the applicable reporting route and period
- Evidence status: Reference unavailable
- Review status: Review pending
- Owner: PMS owner (fictional role)
- Next action: The filename is listed, but the document is unavailable in this fictional package. Obtain it and confirm whether a PMS report or PSUR applies.
- Reviewer / review date: blank; no completed review is claimed.

## Use these examples

Record document presence separately from adequacy. An unresolved excerpt or unavailable reference does not establish that the whole technical file lacks evidence. Document applicability rationale and the next action, then refer the item to the responsible specialist.

- Workbook, CSV and outline: https://conformo.ai/templates/mdr-technical-file-template
- Preparation guide: https://conformo.ai/learn/mdr