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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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Your technical documentation

Through the technical documentation, you, as the manufacturer, provide evidence that your medical device complies with European Union regulations and meets the requirements for CE marking. Technical documentation is essential for obtaining medical device approval in the EU.

Your technical documentation

Through the technical documentation, you, as the manufacturer, provide evidence that your medical device complies with European Union regulations and meets the requirements for CE marking. Technical documentation is essential for obtaining medical device approval in the EU.

General structure of technical documentation (MDR/IVDR)

1. Device description

  • Name, General Description, Basic UDI-DI
  • Intended use, claims, patients, users, conditions, contraindications, warnings
  • Operating principles & mode of action
  • Classification including rule justification, rationale for classification as a device
  • Description, configuration, variants, accessories, other devices and combinations
  • Key functional elements (parts/formulation / composition / functionality)
  • Raw materials (of key functional elements & of parts with indirect/direct body contact)
  • Technical Specifications (Features/dimensions / performance attributes in specs made available to user)
  • Previous generations & similar devices on markets

2. Information supplied

  • Labels
  • Instructions for Use

3. Design & manufacturing

  • Design Stages applied (Design Control)
  • Design & Manufacturing specifications
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • Final product testing / Quality Control Plan
  • Site identification (All sites, suppliers, subcontractors with design/manufacturing actitivies)

4. General safety and performance requirements

  • List of applied standards including Common Specifications
  • GSPR Checklist / Matrix
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • GSPR link to verification/validation including precise identity of evidence documents for each harmonised standard and Common Specification

5. Risk management

  • Risk Management Plan
  • Risk Management Methods, e.g. Preliminary Hazard Analysis, D-FMEA, P-FMEA, FTA, HAZOP, HACCP
  • Risk Management Report, including benefit-risk analysis

6. Design verification & validation

  • Clinical / Performance Evaluation Plan
  • Clinical / Performance Evaluation Report
  • Usability (where applicable)
  • Performance and Safety Test Results
  • Physical, Chemical & Microbiological Characterisation
  • Biocompatibility (where applicable)
  • Stability & Shelf Life
  • Reprocessing
  • Electrical Safety (where applicable)
  • Software Verification & Validation (where applicable)
  • Information on test design, test protocols, data analysis methods, data summaries and test conclusions

7. Post-market surveillance (Annex III)

  • Post Market Clinical Follow Up (PMCF) Plan & Report
  • PMS Plan & Report
  • Periodic safety update report (PSUR)

General structure of technical documentation (MDR/IVDR)

1. Device description

  • Name, General Description, Basic UDI-DI
  • Intended use, claims, patients, users, conditions, contraindications, warnings
  • Operating principles & mode of action
  • Classification including rule justification, rationale for classification as a device
  • Description, configuration, variants, accessories, other devices and combinations
  • Key functional elements (parts/formulation / composition / functionality)
  • Raw materials (of key functional elements & of parts with indirect/direct body contact)
  • Technical Specifications (Features/dimensions / performance attributes in specs made available to user)
  • Previous generations & similar devices on markets

2. Information supplied

  • Labels
  • Instructions for Use

3. Design & manufacturing

  • Design Stages applied (Design Control)
  • Design & Manufacturing specifications
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • Final product testing / Quality Control Plan
  • Site identification (All sites, suppliers, subcontractors with design/manufacturing actitivies)

4. General safety and performance requirements

  • List of applied standards including Common Specifications
  • GSPR Checklist / Matrix
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • GSPR link to verification/validation including precise identity of evidence documents for each harmonised standard and Common Specification

5. Risk management

  • Risk Management Plan
  • Risk Management Methods, e.g. Preliminary Hazard Analysis, D-FMEA, P-FMEA, FTA, HAZOP, HACCP
  • Risk Management Report, including benefit-risk analysis

6. Design verification & validation

  • Clinical / Performance Evaluation Plan
  • Clinical / Performance Evaluation Report
  • Usability (where applicable)
  • Performance and Safety Test Results
  • Physical, Chemical & Microbiological Characterisation
  • Biocompatibility (where applicable)
  • Stability & Shelf Life
  • Reprocessing
  • Electrical Safety (where applicable)
  • Software Verification & Validation (where applicable)
  • Information on test design, test protocols, data analysis methods, data summaries and test conclusions

7. Post-market surveillance (Annex III)

  • Post Market Clinical Follow Up (PMCF) Plan & Report
  • PMS Plan & Report
  • Periodic safety update report (PSUR)

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.

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.

Having expertly prepared technical documentation enables smooth regulatory approvals and straightforward maintenance of CE marking.

Having expertly prepared technical documentation enables smooth regulatory approvals and straightforward maintenance of CE marking.

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

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 >>


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.

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

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.