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.
EUDAMED registration for medical device manufacturers
Your documents become registration data you can verify.
We prepare your device data for EUDAMED and resolve open points. After the expert review and your documented sign-off as the manufacturer, we submit it by XML bulk upload in your own EUDAMED account.
A binding fixed price once we have reviewed your product list. We work in German, English and Turkish.
Who does what
- Prepare and clarifyMedregia
- Expert reviewYour RA team, your consultant or an expert named in the proposal
- Documented sign-offYou, as the manufacturer
- Submit by XML bulk uploadMedregia, in your own EUDAMED account
Device registration deadlines
- First placed on the market before 28 May 2026 and still placed on the market after that date
- Registration by 28 November 2026
- First placed on the market on or after 28 May 2026
- Registration before placing on the market
Exemptions apply, among others, to custom-made devices and to devices of which no unit has been placed on the market since 28 May 2026. Deadlines, exemptions and sources
Sample file
Every value with its origin. Every open question in plain sight.
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.
Division of work
What your team contributes and what Medregia takes on.
You provide what you have. We turn it into registration data. Expert review and sign-off remain separate steps.
| Task | Your team | Medregia |
|---|---|---|
| Documents | Provide the documents you already have: product list, data sheets, instructions for use, certificates. | Review the documents and transfer the existing details for Basic UDI-DI, UDI-DI and other mandatory fields; for legacy devices, EUDAMED DI and EUDAMED ID. |
| Open points | Answer the open points on the clarification list. | Check for completeness. Record gaps and contradictions in a clarification list instead of guessing. |
| Expert review | Expert review by your RA team, your consultant or an expert named in the proposal. | Provide the prepared details with sources and the clarification list for review. |
| Sign-off | Give your documented sign-off as the manufacturer. | Nothing is submitted without your documented sign-off. |
| Submission | Give Medregia user access to your EUDAMED account. | Generate the data as XML and submit it by XML bulk upload in your own EUDAMED account. |
Who carries out the expert review: two routes
With your RA team or consultant
We prepare the data and record open points on the clarification list. The expert review is carried out by your RA team or your consultant. After your documented sign-off as the manufacturer, we submit by XML bulk upload in your own EUDAMED account.
With an expert named in the proposal
The expert review is carried out by an expert named in the proposal, who documents the review verdict with name and date. After your documented sign-off as the manufacturer, we submit the data by XML bulk upload in your own EUDAMED account. The expert's verdict does not replace your sign-off.
In every case, regulatory responsibility remains with the manufacturer.
Process
Four steps, each with a tangible result.
-
Review the product list
You send your product list or documents through an agreed channel. We review the portfolio, propose device families and identify what is missing.
Result: A proposal with a binding fixed price, optionally as a limited initial order for one device family.
-
Prepare and clarify
We transfer the existing details for each device, check them for completeness and record open points in a clarification list. Your team answers the queries and confirms the details for each device family.
Result: A record with sources for each device and a completed clarification list.
-
Expert review and sign-off
The expert review is carried out by your RA team, your consultant or an expert named in the proposal. You then give your documented sign-off as the manufacturer.
Result: A documented expert review and your documented sign-off.
-
Submit
After your sign-off we submit the data by XML bulk upload in your own EUDAMED account.
Result: The submission in your account and EUDAMED's technical response.
Price and initial order
A fixed price once we have reviewed your product list.
We provide a binding fixed-price quote after reviewing your product list. To get started, we recommend a limited initial order with one device family.
How the price is set
There is no flat price per product. The effort depends mainly on the number of device families and variants and on the quality of your documents. After the review we provide a binding fixed-price quote for the agreed scope.
Start with one device family if you wish
A limited initial order with one device family. The fixed price is agreed and paid before we start.
Payment
The initial order is paid before work starts. The payment terms for any further order are set out in the respective proposal.
Submission after your sign-off
After the expert review and your documented sign-off, we submit the data in your own EUDAMED account. Regulatory responsibility remains with you as the manufacturer.
People and confidentiality
Who works on your project.
- Founder and your contact
- Lukas Efrahim Zenker founded Medregia and runs it as a sole trader in Rosenheim, Germany. He is your contact from the first enquiry to submission.
- Expert review
- Your RA team, your consultant or an expert named in the proposal. Software does not replace this review.
- Sign-off
- You give the documented sign-off as the manufacturer after the expert review. Only then do we submit.
- Regulatory responsibility
- Remains with the manufacturer. Medregia does not give legal advice.
- Languages
- We work in German, English and Turkish.
How we handle your documents
- Customer account: the data is held in a database with its storage location in Frankfurt am Main. As the privacy policy explains, access by the database provider from the USA for operation and support cannot be ruled out. Transfers are encrypted, and customer, expert and administration have separate access.
- File analysis in the customer account: for the preparation we use an AI model via Anthropic's interface. Processing takes place in the USA on the basis of EU standard contractual clauses. Under the provider's contractual terms, your data is not used for training.
- Ready-Check on medregia.eu: no AI, checked in the Frankfurt am Main server region, and the file is discarded after the check. If you do not enter an email address, we store neither the file nor the result.
- If we process personal data on your behalf, we conclude a data processing agreement before we start. If you would like a non-disclosure agreement before handing over documents, please let us know. Details are set out in the privacy policy.
Project check
Four questions, initial guidance straight away.
No email, no upload. You immediately receive initial guidance: which way of working fits, what we take on, what stays with you and which documents we need. No price quote, delivery commitment or regulatory assessment at this stage.
The project check is starting. If it does not appear, please write to us at kontakt@medregia.eu.
Questions
Frequently asked questions
Why is there no price per product?
The effort depends mainly on the number of device families and variants and on the quality of your documents. Two products with identical details mean less work than two products with details of their own. That is why we review your product list first and then name a binding fixed price for the agreed scope.
Which deadlines apply to registration?
If the first unit of a device is placed on the market on or after 28 May 2026, the device must be registered in EUDAMED beforehand. If the first unit was placed on the market before 28 May 2026 and further units are placed on the market after that date, the deadline is 28 November 2026. This applies to devices under the MDR and to legacy devices, meaning devices still placed on the market on the basis of the former directives under the transitional provisions of Article 120 MDR. Exemptions: custom-made devices and investigational devices are not registered in the UDI/Device module. Devices of which no unit has been placed on the market since 28 May 2026 only need to be registered if a vigilance or post-market surveillance report requires it. A legacy device does not need to be registered additionally if the same device is already registered under the MDR. For your specific case, an expert review is advisable; we do not give legal advice.
Who carries out the expert review, and who signs off?
The expert review is carried out by your RA team, your consultant or an expert named in the proposal; we agree this with you and record it in the proposal. After the review you give your documented sign-off as the manufacturer. An expert's review verdict does not replace this sign-off. Only then do we submit the data by XML bulk upload in your own EUDAMED account. Software does not replace the expert review. Regulatory responsibility remains with the manufacturer.
What happens to my data?
There are two distinct routes. First, the Ready-Check on medregia.eu: no AI, checked in the Frankfurt am Main server region, and the file is discarded after the check. If you do not enter an email address, we store neither the file nor the result. Second, the file analysis in the customer account: for this we use an AI model via Anthropic's interface. Processing takes place in the USA on the basis of EU standard contractual clauses. Under the provider's contractual terms, your data is not used for training. Account data is held in a database with its storage location in Frankfurt am Main; access by the provider from the USA for operation and support cannot be ruled out. If we process personal data on your behalf, we conclude a data processing agreement before we start. Details are set out in the privacy policy.
Contact
Prefer to write directly?
Write to us at kontakt@medregia.eu. It helps if you mention your product groups, the language of your documents and your preferred timeframe. Please send documents only once we have agreed how to transfer them.