Service
Scope of service and responsibilities
Medregia prepares medical device manufacturers' existing device data for EUDAMED, records open points and submits after the expert review and your sign-off. You know the fixed price before you place an order.
What is included and what stays with you
Included in the project
- Review of your product list and a proposal for device families.
- Preparation of the existing details for Basic UDI-DI, UDI-DI and other mandatory fields for each device.
- Preparation of the data for legacy devices.
- A completeness check and a clarification list with all open points.
- After your documented sign-off, submission by XML bulk upload in your own EUDAMED account.
What stays with you
- Providing the documents you have and answering the clarification list.
- The expert review by your RA team or consultant, unless an expert named in the proposal carries it out.
- The documented sign-off as the manufacturer.
- Your EUDAMED account, your SRN and your regulatory responsibility as the manufacturer.
Who the service is for
For small and medium-sized medical device manufacturers with many products and variants, in particular in these areas:
For a partnership, we approach regulatory affairs consultancies and EU authorised representatives.
Division of work, step by step
For each work step, the table shows what your team contributes and what Medregia takes on.
| 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. |
| Device families | Confirm the details for each device family. | Transfer the shared details of a device family once and reference their source. |
| 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.
We agree the review arrangement with you and record it in the proposal. In both cases you give the documented sign-off as the manufacturer, and regulatory responsibility remains with the manufacturer.
How the fixed price is set
We provide a binding fixed-price quote after reviewing your product list, before you place an order.
What the effort depends on
- Number of device families
- Shared details are recorded and evidenced once per family.
- Number of records per family
- Variants that share details need less work than deviations that have to be reviewed separately.
- Quality of the documents
- A structured list is processed faster than catalogues and PDFs.
- Division of work
- Whether your team or consultant carries out the review, or an expert named in the proposal.
What the proposal states
The proposal states the device families and records, the services included, who carries out the expert review, the fixed price and the payment terms.
Payment
The initial order is paid before work starts. The payment terms for any further order are set out in the respective proposal.
Start with one device family if you wish
To get started, we recommend a limited initial order.
- One device family. The proposal states the exact scope.
- Fixed price, agreed and paid before we start.
- You decide on further device families after the initial order.
After registration
Registration reflects the situation at a point in time. New products, certificate changes or changed details have to be updated in EUDAMED. Whether and to what extent Medregia supports this is agreed separately; it is not part of the initial order.
Limits of the service
So that responsibility and results stay unambiguous:
- Medregia does not give legal advice. Regulatory responsibility remains with the manufacturer.
- Medregia does not assign UDIs and does not determine risk classes. These details come from your documents.
- Software does not replace the expert review, and Medregia does not sign off on the manufacturer's behalf.
- Technical acceptance by EUDAMED is not regulatory approval by an authority.
- We do not promise a successful registration, freedom from errors or particular dates.
- We do not name a price before we have reviewed your product list.
For consultants and EU authorised representatives
You keep the client relationship and can carry out the expert review. The documented sign-off is given by the manufacturer. We prepare the data, keep the clarification list and, after the sign-off, submit by XML bulk upload in the manufacturer's account. We work in German, English or Turkish.
We discuss the process and the collaboration with you directly.
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.