Free EU MDR Templates
Our free, open-source and no-strings-attached templates for EU MDR compliance.
Covering ISO 13485, IEC 62304, ISO 14971 and IEC 62366.
Download them now for free as Word, PDF, Markdown or HTML files.
General MDR Documents
ISO 13485 Templates
IEC 62304 Templates
IEC 62366 Templates
ISO 14971 Templates
Clinical Evaluation Templates
IVDR Templates
GDPR Templates
ISO 27001 Templates
General MDR Documents
View all 6 templates →
Document Template
MDD Essential Requirements
Dr. Oliver Eidel
updated 5 months ago
Document Template
Checklist: MDR General Safety and Performance Requirements
Sven Piechottka
updated 5 months ago
Document Template
MDR Classification Document
Sven Piechottka
updated 8 months ago
Document Template
Instructions for Use (IfU)
Sven Piechottka
updated 8 months ago
ISO 13485 Templates
View all 37 templates →
Document Template
Software Validation Form
Sven Piechottka
updated 8 months ago
Document Template
Quality Manual, Policy, Objectives
Dr. Oliver Eidel
updated 8 months ago
Document Template
SOP Management Review
Sven Piechottka
updated 8 months ago
Document Template
SOP Document and Record Control
Dr. Oliver Eidel
updated 8 months ago
IEC 62304 Templates
View all 24 templates →
Document Template
SOP Integrated Software Development
Dr. Oliver Eidel
updated 5 months ago
Document Template
Software Development and Maintenance Plan
Dr. Oliver Eidel
updated 8 months ago
Document Template
SOUP List (Software of Unknown Provenance)
Dr. Oliver Eidel
updated about 1 year ago
Document Template
User Needs List
Sven Piechottka
updated about 1 year ago
IEC 62366 Templates
View all 5 templates →
Document Template
IEC 62366-1:2015 Mapping of Requirements to Documents
Dr. Oliver Eidel
updated 11 months ago
Document Template
Usability Evaluation Plan
Dr. Oliver Eidel
updated about 1 year ago
Document Template
Usability Evaluation Protocol
Dr. Oliver Eidel
updated about 1 year ago
Document Template
Usability Evaluation Report
Dr. Oliver Eidel
updated about 1 year ago
ISO 14971 Templates
View all 5 templates →
Document Template
Risk Management Report
Dr. Oliver Eidel
updated 5 months ago
Document Template
Risk Management Plan
Dr. Oliver Eidel
updated 5 months ago
Document Template
Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"
Dr. Oliver Eidel
updated 9 months ago
Document Template
ISO 14971:2019 Mapping of Requirements to Documents
Dr. Oliver Eidel
updated 9 months ago
Clinical Evaluation Templates
View all 4 templates →
Document Template
Clinical Evaluation Plan
Dr. Oliver Eidel
updated about 1 year ago
Document Template
S
Literature Evaluation Table (MDR Clinical Evaluation)
Sebastian Skorka
updated about 1 year ago
Document Template
S
Checklist: Clinical Evaluation Report
Sebastian Skorka
updated about 1 year ago
Document Template
Clinical Evaluation Report
Dr. Oliver Eidel
updated about 1 year ago
IVDR Templates
View all 2 templates →GDPR Templates
View all 4 templates →
Document Template
Technical and Organizational Measures
Sven Piechottka
updated about 1 year ago
Document Template
List of Data Processing Activities with Data Protection Impact Assessment (DPIA)
Sven Piechottka
updated about 1 year ago
Document Template
Data Protection Statement (Privacy Policy)
Sven Piechottka
updated about 1 year ago
Document Template
Employee Data Protection and Confidentiality Agreement
Sven Piechottka
updated about 1 year ago
ISO 27001 Templates
View all 4 templates →
Document Template
SOP Information Security Risk Assessment
Dr. Oliver Eidel
updated about 1 year ago
Document Template
Information Security Policy And Scope
Dr. Oliver Eidel
updated about 1 year ago
Document Template
Information Security Controls
Dr. Oliver Eidel
updated about 1 year ago
Document Template
ISO 27001:2023 Mapping of Requirements to Documents
Dr. Oliver Eidel
updated about 1 year ago