Read the technical-file tracker
Understand every document row created for an MDR or IVDR case.
Technical file and documents
Where to find it
My Cases → Your case → Technical file
You need
- A client case.
The tracker is a case manifest. A row identifies expected work; it does not mean a document has been generated, issued or delivered.
| Regulation | Document | Plain-language purpose |
|---|---|---|
| MDR | Device Description and Specification | Describes what your device is and what it does. |
| MDR | General Safety and Performance Requirements (GSPR) Checklist | Maps your device against the EU safety and performance rules. |
| MDR | Clinical Evaluation Plan | How you will prove the device works for patients. |
| MDR | Clinical Evaluation Report | The written-up evidence that it works. |
| MDR | Risk Management Plan | How you will find and control risks. |
| MDR | Risk Management File | The full record of every risk and its mitigation. |
| MDR | Post-Market Surveillance Plan | How you will watch the device once it is on the market. |
| MDR | Periodic Safety Update Report (PSUR) | A regular safety summary after launch. |
| MDR | Post-Market Clinical Follow-up Plan | Ongoing clinical data collection after launch. |
| MDR | Verification and Validation Plan | What will be tested to show the device works and is safe. |
| MDR | Verification and Validation Report | The test results, and the reports they come from. |
| MDR | Instructions for Use (IFU) | The instructions users get with the device. |
| MDR | Labeling | What goes on the device and its packaging. |
| MDR | EU Declaration of Conformity | Your formal statement that it meets the MDR. |
| MDR | UDI/EUDAMED Registration | Registering the device in the EU database. |
| MDR | QMS Regulatory Evidence Summary | Your quality-management system records. |
| IVDR | Device Description and Intended Purpose (IVD) | Describes what your IVD is, who uses it, and how it is classified. |
What happens next
- Open a row to read its current status, gaps or available document view.
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Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices