How we work
From product list to submission
Here is how we handle your EUDAMED registration project. Each step ends with a result that you can check.
The process in four steps
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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.
Your part: Provide the documents you have. To start with, the product list is enough.
Result: A proposal with a binding fixed price, optionally as a limited initial order for one device family.
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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.
Your part: Answer open points and confirm the details for each device family.
Result: A record with sources for each device and a completed clarification list.
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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.
Your part: Organise the expert review if your team or consultant carries it out, and give the sign-off.
Result: A documented expert review and your documented sign-off.
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Submit
After your sign-off we submit the data by XML bulk upload in your own EUDAMED account.
Your part: Give Medregia user access to your EUDAMED account.
Result: The submission in your account and EUDAMED's technical response.
How it starts
You send your product list or describe your portfolio in the project check. We review it, propose device families and identify open points. You then receive a proposal with a binding fixed price.
Once you have placed the order and paid for the initial order, we agree how your documents are transferred and start with the agreed device family.
A clarification list instead of silent assumptions
Every value states where it comes from: your list, a data sheet, the instructions for use or a query to your team.
Anything without evidence appears as an open question in the file and on the clarification list. We do not guess; we ask.
Every value with its origin. Every open question in plain sight.
Expert review and sign-off
The expert review is carried out by your RA team, your consultant or an expert named in the proposal. The review verdict is documented with name and date. Software does not replace this review.
You then give the documented sign-off as the manufacturer. It is a separate step: a review verdict by your consultant or the named expert does not replace it.
We submit only after your documented sign-off as the manufacturer.
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 the sample, the expert review covers five check points
- EMDN code confirmed against the official nomenclature.
- Risk class and application of the rule under Annex VIII MDR confirmed.
- Intended purpose compared with the instructions for use.
- Mandatory fields complete or gaps resolved.
- Device descriptions reviewed.
Submission in your EUDAMED account
- Submission takes place in your own EUDAMED account under your SRN. The prerequisite is that Medregia has user access there.
- The data is generated as XML in the EUDAMED data exchange format, checked technically against the schema before upload and submitted by XML bulk upload.
- You receive EUDAMED's technical response to the submission. Technical acceptance is not regulatory approval by an authority.
Would you rather enter the data yourself? Then you take over the submission, and we hand over the prepared data in the form agreed in the proposal.
What is documented
- For each device, a record with the source of every value.
- The clarification list with all open points and how they were resolved.
- The expert review with name, date and review verdict.
- Your documented sign-off as the manufacturer.
- The submission and EUDAMED's technical response.
The log evidences the process, not that every entry is correct in substance.
Registration is not approval
These terms describe different steps with different parties involved.
| Term | Meaning | Who |
|---|---|---|
| Expert review | A review of the content of the prepared details against documents and rules. | Your RA team, your consultant or the expert named in the proposal |
| Sign-off | The manufacturer's documented decision after the expert review, with name and date. A prerequisite for submission. | The manufacturer |
| Submission | Transfer of the registration data to EUDAMED in your account. | Medregia by XML bulk upload in your account, or your team |
| Technical acceptance | EUDAMED's response that the data has been technically accepted. It is not an assessment of the content and not regulatory approval by an authority. | EUDAMED |
| Regulatory responsibility | Responsibility for the accuracy and lawfulness of the details and of the device. | The manufacturer |
People and confidentiality
- 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.
Clarify scope and way of working in four questions.
The project check gives you initial guidance straight away. Afterwards you can request a project proposal if you wish.
Or write to us directly at kontakt@medregia.eu.