GxP and Medical Device Compliance Services

CE Marking - Technical File / Design Dossier (FDA)

Technical file includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. Consultys can guide you through all requirements

 

Technical File / Design Dossier (DHF)

A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of your device intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in Europe's CE Marking process and a requirement for compliance with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.

Europe's new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for medical devices and IVDs. Emergo can assist with the MDR/IVDR transition process.
 

CE Technical File and Design Dossier Requirements

Your technical file or dossier includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb and III) but no two files are the same because the type of device dictates the information included therein.

 
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Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is essential. This documentation demonstrates compliance with essential requirements (Annex I of the 93/42/EEC).

Minimum content of technical file should include:

  1. Table of contents

  2. General information concerning the structure and use

  3. EC declaration of conformity and classification to 93/42/EEC annex IX

  4. Name and address of the manufacturer / European Representative and any manufacturing plants

  5. Product description

  6. Product specifications

  7. Product verification

  8. Product validation

    • Validation of the packaging/ageing studies

    • Process validation (e.g. sterilization, manufacturing, production)

    • Software validation

The working group of Notified Bodies has issued recommendations for the structure of the technical file in the guidance NB-MED/2.5.1/Rec.5 rev.4 “Technical Documentation”.

The technical file should in any case be available in an official language of an EU member state and available on request for the whole product life cycle, but at least for a period of 5 years from the production of the last product, with the authorised representative in the EU.

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Consultys supports in mastering Technical File / Design History Files (DHF)
for new and existing medical devices in a fast and
efficient project approach

 

Technical File and Design Dossier compilation services

Consultys specializes in helping medical device and IVD companies achieve CE Marking certification / U.S. market access and we have
done so for serval of devices.

Technical File and Design of Medical Devices

Technical File and Design Dossier compilation

  • Determine exactly which materials need to be compiled
  • Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
  • Evaluate and identify gaps or deficiencies in your documentation
  • Compile EU/FDA Technical File or Design Dossier, with internal peer review
  • Determine applicable testing requirements and standards for your device
  • Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary
  • Review your proposed labeling and Instructions for Use
Software Dossier Creation based on IEC 62304

Software Dossier compilation (IEC 62304, FDA)

  • Support in creating compliant "software documentation" based on IEC 62304 and FDA regulations, including:
    • Software Development plan
    • Software Requirements Specification
    • Software Architecture and detailed design
    • Software Verification (e.g. code reviews, unit test, integration test as well as system test)
    • Software validation (for standalone software) and formal Software release
  • Reverse Software Documentation and Requirements Engineering, also for Legacy Systems / SW
  • SOP Software Development Landscape
Medical Device Risk Management ISO14971

Risk Management (ISO 14971)

  • Creation of a risk management plan, which is aligned to "SOP risk management" (in case there is none we can help, too)
  • Evaluation of intended use (Requirement of ISO 14971 chapter 4.2)
  • Creation risk acceptance matrix
  • Execution of risk analysis (PHA, FTA, FMEA) specifically for system and software
  • Assess possibilities and severities of harms and therefore the risks
  • Support and advisory for measures in risk mitigation and risk control
  • Design a system for market surveillance and concise, precise and documentation fully compliant with ISO 14971



 

Medical Device ALM for efficient Design History File Management
 

A Medical Device ALM Software can help to create, manage and trace the Design Control Items of a Design History File. By spending less time on regulatory documentation, you can free up valuable resources for innovation. ALM tools integrating and tracing all Design Control Items in your application lifecycle with full traceability into one single application, including:

  • Requirements, specifications and use cases

  • Risks, Hazards and Mitigations

  • Verification and Validation tests

  • Design Reviews, Documents, Issues

This not only eliminates the extra effort of manually merging and mapping information across separate systems but also provides excellent opportunity for automatic end-to-end consistency monitoring of your Design History File.

Learn more about Aligned Elements: http://www.aligned.ch/

Contact our Technical File and Design Dossier Team

Please contact us to learn more about our CE Technical File preparation services for medical devices and IVD manufacturers.