EU MDR Technical File vs Design Dossier: What’s the Difference?
If you’ve worked under the old Medical Devices Directive (MDD), you probably remember hearing both “technical file” and “design dossier” and wondering which one applied to you. Under EU MDR 2017/745, the picture is simpler. Here’s what each term means and what you actually need to prepare.
What Is an EU MDR Technical File?
The technical file, which MDR calls “technical documentation,” is the full set of evidence showing your device meets the General Safety and Performance Requirements (GSPRs). It covers the device’s design, intended purpose, manufacturing process, risk management, clinical evaluation, and performance. When a notified body or authority asks “how do you know this device is safe and works?”, this is where the answer lives.
Technical File vs Design Dossier
Under the MDD, the two terms were tied to device class. Lower-risk devices generally needed a technical file, while certain higher-risk devices went through notified body assessment of a design dossier. The line between them was often confusing.
MDR removes that split. Every manufacturer now maintains technical documentation structured under Annex II and Annex III, whatever the device class. What changes with risk is the depth: a Class III implant needs far more detail and evidence than a Class I device, but both follow the same structure.
What Goes Into the File
Here’s what a technical file typically contains:
- Device description: What the device is, its intended purpose, and its classification.
- Design and manufacturing information: Specifications, materials, and how the device is made.
- Risk management: The risks you’ve identified, how you evaluated them, and what you did about them.
- Clinical evaluation: The clinical evidence behind your safety and performance claims.
- GSPR checklist: A requirement-by-requirement table showing how you meet each applicable GSPR, and where the supporting evidence sits.
- Post-market surveillance: Your PMS plan, reports, and any follow-up documentation.
Why Getting It Right Matters
A clear, well-organized file makes notified body reviews much smoother. Gaps and inconsistencies between documents, such as a risk file that doesn’t match the clinical evaluation, are a common source of review questions. The file also isn’t something you finish and forget. Update it whenever your design, intended purpose, or the regulations change.
How MASUU Global Can Help
At MASUU Global, we provide regulatory consulting and technical documentation support, helping manufacturers build an EU MDR technical file that meets the requirements and supports market access.