Evidence: Basic UDI-DI
Source document
The manufacturer's product list.
Value transferred
Value transferred unchanged from the product list.
Open question
No open question.
Documented review
Check point 4, mandatory fields complete: checked.
Samples
What a result looks like
All samples contain fictitious data. They show how we evidence values, document clarifications and record the process up to submission: data preparation, expert review, sign-off by the manufacturer, submission in the manufacturer's EUDAMED account and the technical response from EUDAMED. The sample decision log is available in German, English and Turkish.
Example Fictitious data: no real device, no real customer, no real reviewer. The SRN DE-MF-000000000, the name Dr. Beispiel and the sample manufacturer are placeholders. None of the samples contains a genuine expert review or sign-off.
The device file
An excerpt from our sample decision log. Select a field in the device file to see the source document, the value transferred, the open question and the documented review. Below that you will find the expert review and the manufacturer's sign-off.
Device file, excerpt
Sample, fictitious data
Musterprodukt Mullkompresse 10x10 cm, steril
Example Example with fictitious data. The device, manufacturer, identifiers and the reviewer are not real. The sample contains no genuine expert review and no genuine sign-off.
| Field | Value | Status |
|---|---|---|
| Basic UDI-DI | 4099999MUSTER0001AB |
transferred |
| UDI-DI | 04099999000017 |
resolved |
| Risk class | Class Is, Rule 4, Annex VIII MDR | transferred |
| EMDN code | M0201020101 Cotton gauzes, folded, sterile |
transferred |
| Intended purpose | from the instructions for use, revision 3 | transferred |
| Sterilisation method | STEAM |
resolved |
| Placed on the market sterile | yes | confirmed |
Status per field: transferred (square), resolved after an open question (diamond), confirmed by the manufacturer (tick).
Evidence: UDI-DI
Source document
The manufacturer's product list. The UDI-DI field is empty.
Value transferred
No value transferred. A missing identifier is never guessed.
Open question
The UDI-DI is missing from the product list. Please add the identifier.
Resolved on 3 September 2026: Your team enters the UDI-DI. The log records the change from empty to 04099999000017.
Documented review
Check point 4: all 28 mandatory fields are filled in.
Evidence: Risk class
Source document
The manufacturer's device details: non-invasive device, contact with injured skin, placed on the market sterile.
Value transferred
Class Is under Rule 4, Annex VIII MDR, transferred from the manufacturer's classification. The rule applied is recorded in the file.
Open question
No open question.
Documented review
Check point 2: risk class and application of the rule confirmed.
Evidence: EMDN code
Source document
The official EMDN nomenclature of the European Commission.
Value transferred
Terminal code M0201020101. Candidates reviewed from the nomenclature: M0201020101 and M020102.
Open question
No open question.
Documented review
Check point 1: EMDN code confirmed against the official nomenclature.
Evidence: Intended purpose
Source document
The manufacturer's instructions for use, revision 3.
Value transferred
Intended purpose transferred from the instructions for use. The wording is not reproduced in the sample.
Open question
No open question.
Documented review
Check point 3: intended purpose matches the instructions for use, rev. 3.
Evidence: Sterilisation method
Source document
Pre-filled value EO. The manufacturer's validation report states steam sterilisation.
Value transferred
Initially EO from the pre-filled value.
Open question
The pre-filled value and the validation report contradict each other. Which method applies?
Resolved on 3 September 2026: Your team changes the value from EO to STEAM. Reason recorded in the log: source data preferred, the validation report states steam sterilisation.
Documented review
Check point 4: evidence of sterilisation supplied subsequently, mandatory fields complete.
Evidence: Placed on the market sterile
Source document
Pre-filled value from the device details.
Value transferred
Value pre-filled and put to your team for confirmation.
Open question
No open question.
Your team confirms the pre-filled value on 3 September 2026.
Documented review
Check point 2: Class Is, meaning placed on the market sterile, confirmed.
Expert review and sign-off
- Expert review by
- Dr. Beispiel placeholder, not a real person
- Date of review
- 4 September 2026
- Review verdict
- 5 of 5 check points reviewed. Class and EMDN checked, no objections.
- Sign-off by the manufacturer
- 7 September 2026, by the sample manufacturer a separate step, documented in the sample log
- Submission
- 8 September 2026 in the sample manufacturer's EUDAMED account
- EUDAMED response
SUCCESSon 9 September 2026. This is technical acceptance, not regulatory approval by an authority.
Values from the sample decision log, as of 26 October 2026, simplified for display.
Chain of events in the sample log
Every stage of the sample file is an event with a timestamp and the party involved. The order follows the process: data preparation, expert review, sign-off by the manufacturer, submission and the technical response from EUDAMED.
| No. | Time | Event | Content | Party |
|---|---|---|---|---|
| 1 | 1 September 2026, 10:00 | File created | Transferred from the manufacturer's product list, with the source of each value recorded. | Medregia |
| 2 | 1 September 2026, 10:00 | Risk class transferred | Class Is under Rule 4, Annex VIII MDR, from the manufacturer's classification. | Medregia |
| 3 | 1 September 2026, 10:00 | EMDN code assigned | M0201020101 checked against the official nomenclature, candidates M0201020101 and M020102. | Medregia |
| 4 | 2 September 2026, 11:30 | Manufacturer's declaration | Legal framework MDR. Reprocessed single-use devices under Article 17 MDR: no. | Manufacturer |
| 5 | 3 September 2026, 13:00 | Open questions resolved | UDI-DI from empty to 04099999000017. Sterilisation method from EO to STEAM; reason: the validation report states steam sterilisation. | Manufacturer |
| 6 | 3 September 2026, 13:05 | Pre-filled values confirmed | Placed on the market sterile, first EU country. A confirmation, not a sign-off. | Manufacturer |
| 7 | 3 September 2026, 13:10 | Details confirmed | 28 of 28 mandatory fields complete. A confirmation, not a sign-off. | Manufacturer |
| 8 | 4 September 2026, 09:15 | Expert review | Dr. Beispiel (placeholder), 5 of 5 check points reviewed, no objections. The review verdict is not a sign-off. | Reviewer |
| 9 | 7 September 2026, 16:00 | Sign-off by the manufacturer | The sample manufacturer (placeholder) signs off the reviewed record for submission. | Manufacturer |
| 10 | 8 September 2026, 08:00 | Submitted to EUDAMED | XML bulk upload DEVICE_POST_MUSTER.xml in the manufacturer's EUDAMED account DE-MF-000000000, one device. | Medregia |
| 11 | 9 September 2026, 08:30 | Technical response from EUDAMED | SUCCESS for 04099999000017. Technical acceptance, not regulatory approval by an authority. | EUDAMED |
The table can be scrolled sideways.
Confirmations by the manufacturer's team during preparation (events 6 and 7) are not a sign-off. The manufacturer gives its sign-off as a separate step after the expert review (event 9); the review verdict does not replace it.
The sample contains no verification key and no hash values because it does not come from a real file.
Review verdict in the sample
| No. | Check point | Checked | Remark |
|---|---|---|---|
| 1 | EMDN code confirmed against the official nomenclature. | yes | M0201020101 is the terminal level for sterile, folded gauze swabs. |
| 2 | Risk class and application of the rule under Annex VIII MDR confirmed. | yes | Rule 4, Annex VIII MDR, contact with injured skin, Class Is. |
| 3 | Intended purpose compared with the instructions for use. | yes | Intended purpose matches the instructions for use, rev. 3. |
| 4 | Mandatory fields complete or gaps resolved. | yes | All 28 mandatory fields filled in, evidence of sterilisation supplied subsequently. |
| 5 | German and English device descriptions reviewed. | yes | German and English device descriptions correct in language and content. |
Conclusion in the sample: file complete, no objections. The reviewer is a placeholder. The review verdict is not a sign-off; the manufacturer then gives its documented sign-off.
Sample files to download
The sample decision log is available in German, English and Turkish, each with the same events and values. The product name, manufacturer name, identifiers and technical codes are unchanged in all versions.
| File | Content | Format | Language |
|---|---|---|---|
| Sample decision log, English version medregia-muster-entscheidungsprotokoll-en.pdf |
The same steps, events and values as the German version. | English. Product name, manufacturer name, identifiers and codes unchanged. | |
| Sample decision log, German version medregia-muster-entscheidungsprotokoll.pdf |
The sample file's process in five steps: data preparation, expert review, sign-off by the manufacturer, XML submission in the manufacturer's EUDAMED account, technical response from EUDAMED. No verification key. | German | |
| Sample decision log, Turkish version medregia-muster-entscheidungsprotokoll-tr.pdf |
The same steps, events and values as the German version. | Turkish. Product name, manufacturer name, identifiers and codes unchanged. | |
| Sample device list medregia-muster-produktliste.csv |
Five fictitious sample devices with the fields for each device. Semicolon-separated, UTF-8. | CSV | Column names in German with technical keys |
| Sample XML for bulk upload medregia-muster-device-post.xml |
DEVICE.POST package generated from the same device list; according to the file header, validated against the EUDAMED data exchange schema XSD 3.0.30. Not intended for upload. | XML | Technical data format, comments in German |
The device list and the XML show five other fictitious sample devices with the same placeholder SRN, GS1 prefix 4099999 and certificate number MUSTER-CE-0000. They are not the submission of the sample file; the decision log shows its single device. No real device, no customer data.
Technical basis
- Official EMDN nomenclature
- We check against the European Commission's EMDN v3 with 8,487 codes across all levels, as of 7 September 2026. No catalogue of our own, no guessed codes.
- Terminal code
- For submission we use the lowest available level of the nomenclature, the terminal code. We do not accept higher-level categories.
- Risk class from your classification
- We transfer the risk class and the rule applied under Annex VIII MDR from your documents; we do not determine them ourselves.
- Field catalogue
- Based on Annex VI MDR. Every mandatory field is recorded and evidenced individually.
- Schema validation before upload
- The submission is generated as DEVICE.POST XML following the official EUDAMED data exchange schema and validated against it before upload. The sample XML states the schema version used in its file header.
Verify a decision log
A decision log from a Medregia file carries a verification key on its first page. Enter it here. We check whether the chain of events is unchanged and report the number of events and the time of the last one. The check does not display content, field values or names.
The check shows that the log is unchanged. It does not show that the details are correct in substance.
The samples on this page contain no verification key because they do not come from a real file, so they cannot be used to try out the check.
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