Skip to content
Docsie Logo

Free Downloadable Template

Free Technical Documentation File (EU MDR) Template

EU MDR Annex II and III technical file for a medical device, from device description to post-market surveillance. Download the editable blank, or create a draft from your recordings in Docsie.

Device Description and Specification Information Supplied by the Manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management Product Verification and Validation Clinical Evaluation
Word PDF Markdown
Create in Docsie All long-form templates

Use this file to assemble controlled device evidence in the definition order of Annex II followed by Annex III. Enter document references and evidence status; an empty record is an evidence gap, not a conformity conclusion. Regulatory applicability and release decisions belong to the authorized reviewers.

Complete bracketed fields with approved information. Duplicate modules and rows as needed; record the reason for any section marked not applicable.

Document [ID and revision] Owner [Role] Scope [Organization, site or product]

Effective date [Date] Approval [Controlled record] Next review [Date or trigger]

Device description and specification

Device identity Controlled description
Name intended purpose and users [Exact labelling wording and source revision]
Patients indications and contraindications [Population and approved claims]
Operating principle and novel features [Description and supporting evidence]
Classification and Basic UDI DI [Class, rule, reviewed rationale and identifier]
Previous or similar generations [Comparison and supporting controlled reference]
Variant or accessory Configuration materials and specification Evidence
[Identifier] [Values, units and compatibility] [Drawing, specification and revision]

Information supplied by the manufacturer

Supplied information Controlled version and scope Consistency review
[Label, IFU or implant card] [Language, variant and document ID] [Purpose, claims and revision check]
[Warning or residual-risk disclosure] [Exact wording, signal word and location] [Linked risk and review result]
[Promotional claim] [Exact claim and channel] [Evidence and labelling consistency]

Design and manufacturing information

Stage or process Site supplier and controls Controlled evidence
[Design stage] [Design output and review gate] [Record and revision]
[Manufacturing step] [Site, subcontractor, parameters and control] [Validation or verification reference]

General safety and performance requirements

Keep one record per requirement and retain the reviewer justification for applicability. Split large matrices by chapter. | Requirement and applicability | Method and cited specification | Evidence and review status | |---|---|---| | [GSPR ID; applicable or justified not applicable] | [Conformity method; standard or common specification and edition] | [Evidence ID, section, version and reviewer finding] | | [GSPR ID] | [Method and exact reference] | [Evidence or open gap] |

Benefit risk analysis and risk management

Risk management element Controlled record and conclusion status
Plan scope and acceptability criteria [Lifecycle phases, method and approved criteria]
Hazard hazardous situation and harm [Risk ID, sequence of events and evidence]
Initial estimation [Severity/probability method and source rating]
Control and verification [Inherent design, protective measure or information; implementation and effectiveness evidence]
Residual risk and disclosure [Recorded evaluation, disclosure and labelling reference]
Overall benefit risk evaluation [Authorized conclusion and evidence; unresolved gaps]
Production feedback [Inputs, review trigger and risk-file update]

Risk control traceability

Risk and control ID Implementation evidence Effectiveness evidence and status
[IDs] [Design or process record] [Test, criterion, result and reviewed conclusion]

Product verification and validation

Preclinical evidence record

Repeat by test area such as software, biocompatibility, packaging, performance or sterilization when applicable. | Test area and requirement | Method configuration and criterion | Result and conclusion | |---|---|---| | [Test ID, risk and requirement] | [Standard edition, device configuration, samples and exact acceptance criterion] | [Report, values, units, deviation and recorded conclusion] | | [Not performed] | [Reviewed rationale and existing data relied on] | [Evidence limitations and decision] |

Clinical evaluation record

Evaluation element Controlled evidence
Plan and claims [Intended purpose, benefits, outcome parameters and plan revision]
Data sources [Investigations, literature or equivalence evidence and comparison]
Appraisal and analysis [Methods, populations, endpoints, statistics and limitations]
Conclusions and gaps [Recorded safety/performance/benefit-risk conclusion and unresolved evidence]
PMCF and clinical follow up [Plan, activities, results and evaluation report references]
Public clinical summary [Where applicable: controlled summary and consistency review]

Evidence cross reference

Claim or GSPR Clinical or test evidence Risk or labelling consistency
[Identifier] [Report and section] [Linked record and reviewer result]

Post market surveillance

Surveillance element Plan or report record
Device scope and objectives [Devices, period and PMS plan reference]
Data sources [Complaints, vigilance, service, literature, registries, feedback or PMCF]
Indicators and trend method [Definition, threshold, unit, rationale and review frequency]
Incident handling and communication [Classification rules, decision authority and applicable reviewed obligations]
Feedback to other files [Risk, clinical evaluation and corrective-action links]
PMS report or PSUR [Applicable report type, period, version, findings and authorized conclusion]
Surveillance finding Assessment and linked action Review evidence
[Source and signal] [Risk or clinical impact; CAPA or update] [Decision, owner and record]

Glossary

Term or abbreviation Approved meaning Defining source
[Term used in the file] [Expansion or definition] [Controlled source]

Technical file readiness review

  • [ ] Device identity, intended purpose, warnings and claims agree across controlled records.
  • [ ] Applicability decisions and conclusions have evidence; no blank result is marked as passed or conforming.
  • [ ] Open risks, deviations and evidence gaps are visible to the release authority. | Reviewer function | Scope and decision | Date reference and open actions | |---|---|---| | [Regulatory, quality or technical role] | [Review scope; approved or returned] | [Controlled approval and gaps] |

8 Repeatable Chapter Patterns

One document plan. The right structure for each chapter.

Teams preparing a technical documentation file (eu mdr) from existing source material. Repeat a procedure, checklist, or reference chapter where needed, and keep only the sections your source material supports.

1

Overview

Set the purpose, scope, audience, and boundaries before the detailed chapters.

2

Reference

Keep exact settings, field values, commands, and supporting references easy to look up.

3

Safety and warnings

Place the relevant hazards, precautions, and source warnings before the actions they affect.

4

Risk management

Connect identified risks to their assessment, controls, review, and retained evidence.

5

Verification and validation

Connect requirements and intended use to the checks, methods, results, and evidence addressing them.

6

Clinical evaluation

Organize the evaluation scope, supporting clinical evidence, analysis, and documented conclusions.

7

Post-market surveillance

Organize post-market information sources, monitoring, review, findings, and follow-up actions.

8

Glossary

Define the terms and abbreviations used throughout the document.

Suggested document outline

  • Device Description and Specification
  • Information Supplied by the Manufacturer
  • Design and Manufacturing Information
  • General Safety and Performance Requirements
  • Benefit-Risk Analysis and Risk Management
  • Product Verification and Validation
  • Clinical Evaluation
  • Post-Market Surveillance

Inside the editable blank

Use this file to assemble controlled device evidence in the definition order of Annex II followed by Annex III. Enter document references and evidence status; an empty record is an evidence gap, not a conformity conclusion. Regulatory applicability and release decisions belong to the authorized reviewers.

Complete bracketed fields with approved information. Duplicate modules and rows as needed; record the reason for any section marked not applicable.

Document [ID and revision] Owner [Role] Scope [Organization, site or product]

Effective date [Date] Approval [Controlled record] Next review [Date or trigger]

Device description and specification

Device identity Controlled description
Name intended purpose and users [Exact labelling wording and source revision]
Patients indications and contraindications [Population and approved claims]
Operating principle and novel features [Description and supporting evidence]
Classification and Basic UDI DI [Class, rule, reviewed rationale and identifier]
Previous or similar generations [Comparison and supporting controlled reference]
Variant or accessory Configuration materials and specification Evidence
[Identifier] [Values, units and compatibility] [Drawing, specification and revision]

Information supplied by the manufacturer

Supplied information Controlled version and scope Consistency review
[Label, IFU or implant card] [Language, variant and document ID] [Purpose, claims and revision check]
[Warning or residual-risk disclosure] [Exact wording, signal word and location] [Linked risk and review result]
[Promotional claim] [Exact claim and channel] [Evidence and labelling consistency]

Design and manufacturing information

Stage or process Site supplier and controls Controlled evidence
[Design stage] [Design output and review gate] [Record and revision]
[Manufacturing step] [Site, subcontractor, parameters and control] [Validation or verification reference]

General safety and performance requirements

Keep one record per requirement and retain the reviewer justification for applicability. Split large matrices by chapter. | Requirement and applicability | Method and cited specification | Evidence and review status | |---|---|---| | [GSPR ID; applicable or justified not applicable] | [Conformity method; standard or common specification and edition] | [Evidence ID, section, version and reviewer finding] | | [GSPR ID] | [Method and exact reference] | [Evidence or open gap] |

Benefit risk analysis and risk management

Risk management element Controlled record and conclusion status
Plan scope and acceptability criteria [Lifecycle phases, method and approved criteria]
Hazard hazardous situation and harm [Risk ID, sequence of events and evidence]
Initial estimation [Severity/probability method and source rating]
Control and verification [Inherent design, protective measure or information; implementation and effectiveness evidence]
Residual risk and disclosure [Recorded evaluation, disclosure and labelling reference]
Overall benefit risk evaluation [Authorized conclusion and evidence; unresolved gaps]
Production feedback [Inputs, review trigger and risk-file update]

Risk control traceability

Risk and control ID Implementation evidence Effectiveness evidence and status
[IDs] [Design or process record] [Test, criterion, result and reviewed conclusion]

Product verification and validation

Preclinical evidence record

Repeat by test area such as software, biocompatibility, packaging, performance or sterilization when applicable. | Test area and requirement | Method configuration and criterion | Result and conclusion | |---|---|---| | [Test ID, risk and requirement] | [Standard edition, device configuration, samples and exact acceptance criterion] | [Report, values, units, deviation and recorded conclusion] | | [Not performed] | [Reviewed rationale and existing data relied on] | [Evidence limitations and decision] |

Clinical evaluation record

Evaluation element Controlled evidence
Plan and claims [Intended purpose, benefits, outcome parameters and plan revision]
Data sources [Investigations, literature or equivalence evidence and comparison]
Appraisal and analysis [Methods, populations, endpoints, statistics and limitations]
Conclusions and gaps [Recorded safety/performance/benefit-risk conclusion and unresolved evidence]
PMCF and clinical follow up [Plan, activities, results and evaluation report references]
Public clinical summary [Where applicable: controlled summary and consistency review]

Evidence cross reference

Claim or GSPR Clinical or test evidence Risk or labelling consistency
[Identifier] [Report and section] [Linked record and reviewer result]

Post market surveillance

Surveillance element Plan or report record
Device scope and objectives [Devices, period and PMS plan reference]
Data sources [Complaints, vigilance, service, literature, registries, feedback or PMCF]
Indicators and trend method [Definition, threshold, unit, rationale and review frequency]
Incident handling and communication [Classification rules, decision authority and applicable reviewed obligations]
Feedback to other files [Risk, clinical evaluation and corrective-action links]
PMS report or PSUR [Applicable report type, period, version, findings and authorized conclusion]
Surveillance finding Assessment and linked action Review evidence
[Source and signal] [Risk or clinical impact; CAPA or update] [Decision, owner and record]

Glossary

Term or abbreviation Approved meaning Defining source
[Term used in the file] [Expansion or definition] [Controlled source]

Technical file readiness review

  • [ ] Device identity, intended purpose, warnings and claims agree across controlled records.
  • [ ] Applicability decisions and conclusions have evidence; no blank result is marked as passed or conforming.
  • [ ] Open risks, deviations and evidence gaps are visible to the release authority. | Reviewer function | Scope and decision | Date reference and open actions | |---|---|---| | [Regulatory, quality or technical role] | [Review scope; approved or returned] | [Controlled approval and gaps] |
Build from your source material

Create your technical documentation file (eu mdr) in Docsie

Bring your recordings and select this template. Docsie organizes supported material into chapters and task articles for your team to review.

Create in Docsie Browse all templates

Downloads are editable blank templates. Review generated content against your source material before use.

More long-form templates

Compliance Program Manual

Compliance program manual built on the elements of an effective program: governance, risk, policies, reporting, review.

Learn More

Documentation Style Guide

House rules for voice, grammar, formatting, UI and code text, and terminology that keep documentation consistent.

Learn More

Information Security Policy Set

Top-level security policy plus topic-specific policies grouped by control theme, aligned to ISO/IEC 27002.

Learn More