# MDR technical-file outline

Conformo Editorial Team · 2026-10-06 · Template version 1.1

Use this outline with the companion Excel workbook or CSV. It organizes Annex II/III preparation topics and controlled evidence references. Adapt it to your device and assessment route. A completed outline does not establish evidence adequacy or conformity.

## Document control

- Device / family:
- Manufacturer:
- Intended purpose and users:
- Variants / software versions in scope:
- File identifier and revision:
- Register owner:
- Assessment context / route:
- Prepared by / date:
- Applicable legal and guidance versions:
- Reviewed by / role / date (only after review):

## Working instructions

1. Review applicability with the responsible specialists. Record reasons and source references for exclusions.
2. Enter each document ID, exact revision and section/page in the companion register. Add another row when a requirement needs another document.
3. Track evidence status and review status separately. A located source still needs scope, consistency and adequacy review.
4. Assign unresolved questions to an owner with a specific next action.
5. Maintain a separate Annex I GSPR matrix for applicable requirements and subclauses, methods and evidence. This outline links to that matrix.

## Annex II 1 — Device description and specification

### Annex II 1.1(a) — Device identity and purpose

Link the device name, description, intended purpose and intended users. Compare the scope with labeling and clinical documents.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(b) — Device identification

Record the Basic UDI-DI where applicable, or another unambiguous product or catalogue identifier that supports traceability.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(c) — Patient and clinical scope

Locate the target population, relevant conditions, selection criteria, indications, contraindications and warnings.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(d) — Operating principle

Reference the operating principle and mode of action, with scientific support where needed.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(e) — Medical-device qualification

Locate the rationale for treating the product as a medical device. Keep the conclusion consistent with the stated intended purpose.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(f) — Classification rationale

Reference the risk class and the justification for the Annex VIII rules applied. Assign unresolved reasoning to a qualified reviewer.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(g) — Novel features

Identify novel features and locate the explanation of their implications for the device.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(h) — Accessories and combinations

List accessories, other devices and other products intended for use with the device. Identify their controlled specifications.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(i) — Variants and configurations

Link a complete list or description of marketed variants and configurations. Identify which are covered by each evidence document.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(j) — Functional elements

Locate the component, software, formulation or composition description and the diagrams needed to understand the device.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(k) — Raw materials

Map key functional materials and direct or indirect body-contact materials to their controlled descriptions.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.1(l) — Technical specifications

Reference specifications for the device, variants and accessories. Compare claimed dimensions, features and performance with user-facing information.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.2(a) — Previous generations

Identify earlier generations made by the manufacturer, where they exist, and link the overview.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 1.2(b) — Similar devices

Identify similar devices available in relevant markets, where they exist, and link the overview. A similar-device listing does not establish clinical equivalence.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex II 2 — Information supplied by the manufacturer

### Annex II 2 — Labels and packaging

Index controlled device and packaging labels, including applicable language versions and special handling information.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 2 — Instructions for use

Index controlled instructions and applicable languages. Resolve scope, warning or revision differences against supporting evidence.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex II 3 — Design and manufacturing

### Annex II 3(a) — Design stages

Locate the records explaining the design stages applied to the device and their controlled outputs.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 3(b) — Manufacturing and validation

Reference process specifications, validation, processing aids, monitoring and final product testing. Add rows where several records support the requirement.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 3(c) — Sites and subcontractors

Identify design and manufacturing sites, suppliers and subcontractors and link their relevant activities.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex II 4 — GSPR demonstration and evidence mapping

### Annex II 4(a) — GSPR applicability

Reference a separate Annex I GSPR matrix listing applicable requirements and reasoned exclusions at the relevant subclause level.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 4(b) — GSPR conformity methods

Locate the methods used to demonstrate each applicable GSPR. Record how adopted solutions are justified, verified and validated.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 4(c) — Standards and specifications

Identify harmonised standards, common specifications or other solutions used, with versions and any partial application.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 4(d) — GSPR evidence references

Check that the separate GSPR matrix points to exact controlled documents and locations. Expand it for each applicable Annex I requirement.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex II 5 — Benefit-risk and risk management

### Annex II 5(a) — Benefit-risk analysis

Locate the benefit-risk analysis for the stated device scope and its supporting clinical and risk references.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 5(b) — Risk-management results

Reference risk-management solutions and results. Check links between hazards, controls, verification, labeling and post-market inputs.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex II 6 — Verification, validation and clinical documentation

### Annex II 6.1(a) — Pre-clinical evidence

Index relevant engineering, laboratory, simulated-use or animal results and literature. Identify the device versions and purposes covered.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Test design and protocols

Locate complete protocols, methods of analysis, summaries and conclusions. Identify acceptance criteria and tested configurations.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Biocompatibility

Reference biological evaluation and evidence for applicable patient or user contact, including identified contact materials.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Physical, chemical and microbial properties

Index applicable characterisation methods, protocols and reports. Record the rationale for the selected evaluations.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Electrical safety and EMC

Locate applicable electrical-safety and electromagnetic-compatibility evidence for the configurations in scope.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Software verification and validation

Reference software design and development records and release-specific verification, validation and testing, including relevant user environments.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Stability and shelf life

Locate evidence supporting the claimed storage conditions and shelf life, where relevant.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(b) — Performance and safety

Map performance and safety claims to the supporting test or evaluation records and their conclusions.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(c) — Clinical evaluation plan

Locate the clinical evaluation plan for the device scope and record the controlled revision.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(c) — Clinical evaluation report

Locate the clinical evaluation report and the evidence supporting its conclusions. Assign adequacy questions to the relevant specialist.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.1(d) — PMCF documentation

Reference the PMCF plan and evaluation report, or the justification for non-applicability. Keep this reference consistent with the PMS plan.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(a) — Integral medicinal substance

If relevant, locate the substance statement, source and safety, quality and usefulness data for the device's purpose.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(b) — Human or animal materials

If relevant, identify tissues, cells or derivatives and reference origin information and the associated conformity evidence.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(c) — Absorbed or dispersed substances

If relevant, locate studies addressing absorption, distribution, metabolism, excretion and applicable safety questions, or justify unavailable studies.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(d) — CMR and endocrine-disrupting substances

If relevant, reference the justification concerning the substances identified by Annex I 10.4.1 and the applicable conditions.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(e) — Sterility and microbial condition

If relevant, locate manufacturing-environment information and packaging, sterilisation and sterility-maintenance validation, including applicable residue testing.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(f) — Measuring function

If relevant, locate the methods and evidence supporting the accuracy stated in the device specifications.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex II 6.2(g) — Connected-device operation

If relevant, describe intended combinations and reference the evidence addressing conformity when devices are connected.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Annex III — Post-market surveillance

### Annex III 1 — PMS plan

Locate the device-specific post-market surveillance plan and record its owner, revision and links to the procedures used to implement it.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(a) — Serious incidents and corrective actions

Locate the plan's sources and collection arrangements for serious incidents, relevant PSUR information and field safety corrective actions.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(a) — Non-serious incidents and trends

Locate sources and collection arrangements for non-serious incidents, undesirable side effects and trend-reporting information.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(a) — Literature and databases

Locate the relevant literature, database or registry sources and how the plan collects and uses them.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(a) — Feedback and complaints

Locate the collection arrangements for feedback and complaints from users, distributors and importers.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(a) — Similar-device information

Locate arrangements for collecting publicly available information about similar devices.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Proactive information collection

Reference systematic collection methods that characterize performance and enable comparison with similar products.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Assessment of PMS data

Locate the methods used to assess the collected post-market data.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Indicators and thresholds

Locate defined indicators and thresholds for ongoing benefit-risk and risk-management reassessment. Do not invent threshold values in this register.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Complaint investigation

Reference methods and tools for investigating complaints and analysing experience from devices in use.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Trend-report methods

Locate the incident trend methods, statistical approach and observation period used for Article 88 reporting.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Communication protocols

Reference communication methods for authorities, notified bodies, economic operators and users.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — PMS implementation procedures

Locate the procedures addressing the manufacturer's obligations under Articles 83, 84 and 86, as applicable.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Corrective-action initiation

Reference procedures for identifying and initiating appropriate measures and corrective actions.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — Device traceability for actions

Locate the tools used to trace and identify devices that might need corrective action.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 1(b) — PMCF within PMS

Check the PMS plan's link to the PMCF plan or a reasoned non-applicability justification. Resolve differences with the clinical documentation.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

### Annex III 2 — PMS report or PSUR

Identify the report applicable under Articles 85 or 86. Record the reporting period, controlled reference and the basis for the device-specific reporting approach.

- Applicability and rationale:
- Evidence references (ID / revision / exact location):
- Evidence status / review status:
- Owner / next action:
- Reviewer / actual review date:

## Final document-control review

- Resolve references to the intended controlled revision.
- Check consistent device scope, intended purpose, users and versions.
- Check the separate GSPR matrix and required device-specific documentation.
- Record outstanding specialist reviews and actions.
- Record approvals only after responsible people complete review.

## Source references

- Regulation (EU) 2017/745: https://eur-lex.europa.eu/eli/reg/2017/745/oj
  Annex II; Annex III; use the applicable amended legal text. Legal basis for the documentation areas. Prompts are Conformo summaries, not verbatim requirements. Check amendments and the assessment route for your device.
- MDR corrigendum, 27 December 2019: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745R%2802%29
  Annex III numbering and trend-report wording. Annex III uses sections 1 and 2. The original publication used 1.1 and 1.2.
- Team-NB technical documentation submission guidance, version 4: https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V4-20260421.pdf
  21 April 2026; pages 7, 26–27. Reference for evidence retrieval, controlled document identification and GSPR mapping. Notified-body guidance can require additional device-specific information.
- BSI MDR documentation submission guidelines: https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf
  2026 edition; page 22, demonstration of conformity with GSPRs. Reference for applicability rationale, methods, standards or common specifications and precise evidence locations.
- MDCG-endorsed documents and other guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
  European Commission guidance index. Select guidance relevant to the device and record the version used in your controlled documentation.

Companion workbook, CSV and fictional examples: https://conformo.ai/templates/mdr-technical-file-template