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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics PRRC under MDR or IVDR Checklists >>
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>
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Technical documentation for medical device software and SW-based medical solutions

We prepare and review technical documentation for software medical devices, AI-enabled healthcare technologies, and digital health platforms under MDR, IVDR, FDA, IEC 62304, risk management, clinical evaluation, and quality system requirements.

Technical documentation for medical device software and SW-based medical solutions

We prepare and review technical documentation for software medical devices, AI-enabled healthcare technologies, and digital health platforms under MDR, IVDR, FDA, IEC 62304, risk management, clinical evaluation, and quality system requirements.

Technical file architecture

Technical documentation is not just a set of documents. It is a structured evidence system demonstrating compliance with MDR and IVDR requirements.

Technical documentation structured compliance evidence Device description intended use, claims, classification Information supplied labels, IFU, user information Design & development design stages and manufacturing GSPR evidence safety and performance requirements Risk management ISO 14971, benefit-risk analysis Verification & validation testing, clinical and software evidence Post-market surveillance PMS, PMCF, PSUR, trend reports Software lifecycle IEC 62304 documentation

Technical documentation serves as the central repository of evidence demonstrating compliance with MDR, IVDR, and other applicable regulatory requirements.

Technical documentation structure

Technical documentation is a structured collection of evidence demonstrating compliance with MDR and IVDR requirements.

Note: Some elements shown below may not be applicable to pure software medical devices. They are included because the structure is intended to cover both software medical devices and software-driven physical medical devices.

Technical documentation
1. Device description
  • Name, general description, Basic UDI-DI
  • Intended use, claims, patients, users, conditions, contraindications and warnings
  • Operating principles and mode of action
  • Classification and rule justification
  • Configuration, variants, accessories and device combinations
  • Key functional elements and functionality
  • Raw materials and body-contacting parts
  • Technical specifications and performance attributes
  • Previous generations and similar devices on the market
2. Information supplied
  • Labels
  • Instructions for use
3. Design and manufacturing
  • Design stages and design control
  • Design and manufacturing specifications
  • Manufacturing processes and process validations
  • Final product testing and quality control plan
  • Site identification for design and manufacturing activities
4. General safety and performance requirements
  • List of applied standards and common specifications
  • GSPR checklist or matrix
  • Manufacturing process evidence linked to GSPRs
  • Verification and validation evidence for each applicable requirement
5. Risk management
  • Risk management plan
  • Risk management methods, such as PHA, D-FMEA, P-FMEA, FTA, HAZOP and HACCP
  • Risk management report, including benefit-risk analysis
6. Design verification and validation
  • Clinical or performance evaluation plan
  • Clinical or performance evaluation report
  • Usability documentation, where applicable
  • Performance and safety test results
  • Physical, chemical and microbiological characterisation
  • Biocompatibility, where applicable
  • Stability and shelf life
  • Reprocessing, where applicable
  • Electrical safety, where applicable
  • Software verification and validation, where applicable
  • Test design, protocols, data analysis, summaries and conclusions
7. Post-market surveillance
  • PMCF plan and report
  • PMS plan and report
  • Periodic safety update report

While the structure and terminology differ from MDR and IVDR requirements, technical documentation also serves as a key source of evidence supporting FDA submissions for software medical devices.

How we can help

We will develop technical documentation that complies with MDR or IVDR for your product. If you already possess technical documentation, we will conduct a gap analysis and fill the gaps to ensure its compliance with the relevant regulation.

Whether pursuing CE marking or preparing for FDA submissions, comprehensive technical documentation provides the foundation for successful regulatory approval.

Whether pursuing CE marking or preparing for FDA submissions, comprehensive technical documentation provides the foundation for successful regulatory approval.

Get in touch

We're ready to help you. Contact us whether you have a question about our solutions or need help with regulatory issues

Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com
 

©2025 MDRC - Medical Devices Regulatory Compliance

Solutions

EU Authorised Representative (EC REP)

PRRC

Technical documentation

Risk management

Clinical evaluation

Notified bodies

Quality management system

Post-market surveillance system

Your products

Medical devices and medical equipment

In vitro diagnostic medical devices

Medical software

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

UDI infographic

EUDAMED registration step by step instruction

ISO 14155:2020 structure and content

MDR-compliant technical file

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>


Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

Read more >>


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We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.

Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

ISO 14155:2020 structure and content

MDR-compliant technical file

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.