Technical File or Design Dossier Compilation
A CE Marking Technical File or Design Dossier (for high-risk Class III devices) is a must-have document for devices to be sold in the EU marketplace. It is a comprehensive description of your device intended to demonstrate compliance with European regulatory 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 Regulation (EU MDR 2017/745) and the In-Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746).
The file contains detailed information about your medical device, its design, function, intended use, claims, composition, and clinical evaluations. It’s essentially an “everything you must know” document for a device.
If you’re going for a CE Mark, then you need to understand what is required of the technical file. Click here to ensure your Technical Documentation Complies with EU Medical Device Regulation 2017/745
Technical File Overview
A technical file comprises a collection of evidence used in a regulatory submission to demonstrate that a product is safe and effective and that you’ve met the requirements for the CE Mark.
One thing to make clear is that the technical file is not exactly the same as a design dossier, which can be seen as slightly more in-depth or advanced than a technical file. In the EU, the design dossier is used for higher-risk medical devices.
Basically, all types of devices entering the EU marketplace will require a technical file. Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function and is classified as lower-risk and will have a self-declaration, which does not require the permission of a Notified Body to review a technical file.
Self-declaration means that your company declares your device has met the required standard. It sounds simple on the face of it, but it does mean that you are also responsible for defining the legal framework applicable to your device and identifying which assessments are necessary (tasks that a third party would otherwise undertake).
A technical file is necessary no matter what classification your device is or which pathway you are taking. You can expect that they will definitely review your file if you are going through a Notified Body.
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), now known as the International Medical Device Regulators Forum (IMDRF). 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.
With the new EU MDR requirements for clinical data and risk assessment, and expanded product scope, technical files will need to be more detailed and robust to demonstrate compliance The EU MDR states that medical device manufacturers must:
- Prepare technical documentation before placing a product on the market.
- Ensure technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market.
- Keep records of technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise).
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Once your technical file is complete, you’ll want to run it through some internal checkpoints before submitting it for final review by a notified body. I recommend conducting your own internal audit review. This should be carried out by a cross-functional team of design and development, quality, regulatory, and even manufacturing stakeholders.
You might also choose to use external consultants to help you if you don’t have the internal expertise available. Rico solutions has a worldwide network of experts who have specific expertise with technical documentation. In fact, we specialise in helping medical device and IVD companies achieve CE Marking certification.
- 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.
A strong structure for your technical documentation helps any reviewers to clearly see and understand your contents. The structure can help you to maintain traceability and highlight any associated risks.
At a minimum, technical documentation should have:
- A device description and specification section. This should also have your unique device identification (UDI) number.
- Labeling and instructions for use. (Note: You will need a translation for the local language of the EU country you plan to enter).
- Detailed information on design and manufacturing. (It is recommended that you make use of flow charts to clearly show processes and relationships). You need to show the manufacturing process, suppliers, and materials used.
- Detailed risk management information in compliance with ISO 14971.
- General Safety and Performance Requirements (GSPR), formerly known as essential requirements. It identifies all the things you must do for your device type. From a design control perspective, the contents of your traceability matrix will assist you with addressing the criteria of GSPR.
- Verification and validation information. In terms of verification and validation, the European Commission places a heavy emphasis on clinical data – not just during design and development, but post-market, too. CERs (Clinical Evaluation Reports) should provide a comprehensive overview of the device’s design and composition, as well as its intended applications and any relevant literature reviews.
- Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR).
