European CE Technical File or Design Dossier Compilation for Medical Devices

ANSWERED ON THIS PAGE:

  • What is a European Technical File/Design Dossier?
  • Which device classes require a Technical File?
  • What is the proper format for Technical Files?
  • How will MDR 2017/745 change EU Technical File requirements?

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. Learn more.

CE Technical File and Design Dossier Requirements for medical device companies

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.

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.

Take a deep dive into European Technical File requirements and download our 8-page white paper.

Emergo offers CE Technical File and Design Dossier compilation services

Emergo specializes in helping medical device and IVD companies achieve CE Marking certification and we have done so for thousands of devices. Here's a checklist of the services we provide:

  • Help you 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 your EU 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.

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

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