Innovation matters most when it reaches the people it was created to serve.
We help address the regulatory requirements that connect medical devices with new markets.
Bringing a medical device to the European market requires much more than completing an MDR checklist.
The intended purpose influences classification. Classification determines the conformity assessment pathway. Device characteristics influence applicable safety and performance requirements. Those requirements lead to risks that must be controlled and those controls must ultimately be supported by appropriate clinical, technical and performance evidence.
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Individual Technical Documentation Support
Bring us the part of the Technical Documentation where you need additional regulatory capacity or expertise.
From Device Description, GSPR and Risk Management to Clinical Evaluation, Verification & Validation, Usability, PMS or PMCF - ELLECOM can work alongside your existing regulatory, quality and engineering teams.
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Bring us the device and the evidence you already have.
ELLECOM coordinates the Technical Documentation project across the applicable Annex II and Annex III requirements from regulatory assessment and documentation architecture through gap identification, document development, evidence integration and preparation for conformity assessment.
Clarity Backed by Expertise
We help manufacturers turn product knowledge, engineering information and existing evidence into clear, structured and traceable EU MDR Technical Documentation - bringing together the regulatory expertise and supporting evidence needed to guide your medical device through conformity assessment and throughout its lifecycle.
Explore the key elements of EU MDR Technical Documentation below. Select any topic to discover how we support its preparation, structure and regulatory alignment.
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A comprehensive Benefit-Risk Analysis and Risk Management File, in accordance with ISO 14971, includes the following documentation:
Procedure for Risk Management
Risk Management Plan
Preliminary Hazard Analysis
Hazard Identification Checklist
Risk Management Analysis
Risk Management Report
Together, these documents form the structured Risk Management File, supporting systematic hazard identification, risk analysis and evaluation, risk control, evaluation of residual risks, and benefit-risk determination throughout the medical device lifecycle.
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A comprehensive Design and Development File includes the following documentation:
Procedure for Design and Development
Design and Development Planning Phase
Design and Development Plan
Product Quality Plan
Design Input Review Checklist
User Needs and Design Input Traceability Matrix
Design Input Review Record
Design Output Requirements and Traceability Matrix
Design Output Review Record
Design Output Review Checklist
Design Change Review Record
Bill of Materials (BOM)
Mechanical Drawings and Schematics File
Design Verification and Validation Plan
Design Verification and Validation Phase Review Record
Design Verification Review Record
Design Validation Review Record
Design and Development Verification and Validation Report
Design Traceability File
Design and Development Transfer Record
Together, these documents provide a structured Design and Development File, supporting the planning, design inputs and outputs, design reviews, verification, validation, design transfer, change control and traceability of the medical device throughout the design and development process.
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A comprehensive Post-Market Surveillance (PMS) File includes the following documentation:
Procedure for Post-Market Surveillance
Post-Market Surveillance Plan
Data Search Protocol
Product Safety Database Assessment Report
Post-Market Surveillance Report
Together, these documents provide a structured Post-Market Surveillance File, supporting the systematic and proactive collection, review and analysis of post-market information to monitor device safety and performance, identify emerging risks and trends, and maintain the continued acceptability of the device’s benefit-risk profile throughout its lifecycle.
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A comprehensive Usability Engineering File includes the following documentation:
Assessment of Comprehensibility of Safety Information
Moderator Manual
Moderator Observation Forms – Usability Evaluation
Participant List
Participant Questionnaires – Usability Evaluation
Record of MDR Usability Requirements
Summary of Observations – Usability Evaluation
User Interface Specification
User Evaluation Plan and Protocol
Usability Engineering File
Usability Evaluation Summary Report
Together, these documents provide a structured Usability Engineering File, supporting the identification of user-interface characteristics, use-related hazards and foreseeable use errors, as well as the planning, execution and documentation of usability evaluations. The documentation supports demonstration that the device can be used safely and effectively by the intended users, for the intended uses and within the intended use environments throughout the medical device lifecycle.
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A comprehensive Biological Evaluation Documentation File includes the following documentation:
Biological Evaluation Plan (BEP)
Material and Contact Characterisation
Biological Evaluation Report (BER)
Chemical / REACH / RoHS Compliance Evidence
Together, these documents provide structured Biological Evaluation Documentation, supporting the assessment of materials, nature and duration of body contact, biological hazards and associated risks, and the biological safety of the medical device in accordance with the applicable requirements of the ISO 10993 series and the medical device risk management process.
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A comprehensive Product Verification and Validation Documentation includes the following:
Product Verification and Validation Plan
Product Verification and Validation Report
Together, these documents provide structured verification and validation evidence supporting demonstration that the medical device meets its specified requirements and that its safety and performance have been appropriately verified and validated.
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The Previous Generation and Similar Device Documentation includes the following:
Previous Generation and Similar Device Assessment
This documentation identifies and evaluates relevant information relating to previous generations of the device and similar devices available on the Union or international markets, providing supporting information for the Technical Documentation, as applicable.
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A comprehensive Transportation and Distribution Stability Documentation includes the following:
Transportation and Distribution Stability Testing Plan
Transportation Simulation Test Record
Together, these documents provide structured evidence supporting the evaluation of the medical device and its packaging under defined transportation and distribution conditions, demonstrating that the product’s integrity, safety and performance are maintained throughout transportation and handling.
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A comprehensive Product-Specific Testing and Validation Documentation may include the following, as applicable:
Testing and Validation Plans
Product-Specific Test Protocols
Test and Validation Reports
Supporting Test Certificates and Laboratory Evidence
The required testing and validation activities are determined on a product-specific basis, considering the device characteristics, intended purpose, design, risk profile, applicable standards and regulatory requirements.
Depending on the medical device, this may include applicable safety, performance, electrical, mechanical, EMC, software, usability, biocompatibility, packaging, sterilization, transportation, stability and shelf-life testing, as relevant.
The resulting test reports and supporting evidence form part of the device-specific Verification and Validation Documentation and support demonstration of conformity with the applicable safety and performance requirements.
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A comprehensive Standards and Common Specifications Assessment includes the following documentation:
Identification of Relevant Standards and Common Specifications
Assessment of Applicable Harmonized Standards
Assessment and Justification of Non-Applicable Standards
Identification of Applicable Common Specifications
Standards Applicability and Compliance Matrix
Together, these documents provide a structured assessment of the standards and Common Specifications applicable to the medical device, supporting identification of relevant regulatory and technical requirements, documented justification of applicability or non-applicability, and demonstration of conformity with the applicable requirements throughout the medical device lifecycle.
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Our adaptable methodology serves manufacturing, retail, professional services, and public sector entities.A comprehensive Clinical Evaluation File includes the following documentation:
Procedure for Clinical Evaluation
Clinical Evaluation Plan (CEP)
Literature Search Protocol and Data Evaluation
Literature Evaluation Report
Clinical Evaluation Report (CER)
Together, these documents provide structured Clinical Evaluation Documentation, supporting the systematic identification, collection, appraisal and analysis of relevant clinical data to evaluate the device’s clinical safety, performance and clinical benefits and to demonstrate conformity with the applicable EU MDR clinical evaluation requirements throughout the medical device lifecycle.
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The EU Declaration of Conformity documentation includes:
EU Declaration of Conformity
The EU Declaration of Conformity is the manufacturer’s formal declaration that the medical device complies with the applicable requirements of the EU Medical Device Regulation (EU) 2017/745 and other applicable Union legislation. It identifies the manufacturer, device, applicable regulatory requirements and conformity assessment information, as applicable.
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A comprehensive Device Description and Specification Documentation includes the following:
Device Description and Specification
Intended Purpose and Intended Users
Device Variants, Models and Accessories
Key Functional and Performance Specifications
Materials and Components
Shelf-Life Determination and Supporting Evidence
Together, these documents provide a structured description of the medical device, its intended purpose, design and technical characteristics, variants and specifications, as well as the supporting evidence for the established shelf life, forming a fundamental part of the Technical Documentation in accordance with EU MDR Annex II.
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The General Safety and Performance Requirements (GSPR) Documentation includes:
General Safety and Performance Requirements (GSPR) Checklist / Matrix
This documentation provides a structured assessment of the applicable General Safety and Performance Requirements, including identification of applicable and non-applicable requirements, methods used to demonstrate conformity, applicable standards or Common Specifications, and cross-references to the supporting evidence within the Technical Documentation, in accordance with EU MDR Annex I.
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The Information to be Supplied by the Manufacturer includes the following documentation:
Product Labelling
Instructions for Use (IFU)
Product Datasheets
Together, these documents provide structured product information and safety information necessary for the identification, intended use, safe handling and appropriate use of the medical device, supporting compliance with the applicable requirements of the EU MDR for information supplied with the device.
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The Supplier and Critical Supplier Management Documentation includes the following:
Supplier Quality Agreement
Critical Supplier Identification and Assessment
Together, these documents support the identification, qualification and control of suppliers, including critical suppliers whose products, components, materials or services may have a significant impact on the safety, performance or quality of the medical device. They also define applicable quality and regulatory responsibilities between the manufacturer and its suppliers.
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The UDI Documentation includes the following:
Basic UDI-DI
UDI-DI
Together, these identifiers support the structured identification and traceability of medical devices in accordance with the applicable EU MDR UDI requirements, including assignment of the Basic UDI-DI at the device-family level and UDI-DI at the individual device/model or packaging level, as applicable.
Do you have a specific question about your device?
Whether it’s about regulatory requirements, technical documentation, quality management, or market access, our team is here to help.
Contact us to discuss your device and your specific requirements.
