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.
What is a Declaration of Conformity (DoC)?
The DoC is a one-page document that "declares" your device is compliant with the applicable directive. It is a legally binding document. The DoC is prepared and signed as the last step in the regulatory process.
How is a Technical File formatted?
Most Technical Files follow Summary TEchnical Document (STED), a harmonized format for submitting information for regulatory approval of devices. The format was created by the former Global Harmonization Task Force (GHTF). However, some NBs publish extensive documents describing their position on content and formatting. Emergo can format your technical file to STED or your Notified Body requirements, as needed.
How will Europe's new Medical Device Regulation (MDR 2017/745) change technical file requirements, contents, and formatting?
The MDR will come into effect in late 2019 or early 2020. With new requirements for clinical data and risk assessment, and an expanded product scope, it is possible that technical files will need to be more detailed and robust to demonstrate compliance with the new regulation. To learn more about the new MDR 2017/745 changes, download our 15-page white paper. Selling an IVD? Download our IVDR 2017/746 white paper.