Deadlines, terms and guides

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.

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.

The initial order with one device family is paid before work starts. You know the fixed price beforehand from the proposal. The payment terms for further orders are set out in the respective proposal.

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.

For each device, a prepared record with sources, a completed clarification list, the documented expert review, your documented sign-off and the submission by XML bulk upload in your EUDAMED account. The proposal states the exact deliverables. Technical acceptance by EUDAMED is not regulatory approval by an authority.

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.

Yes. A limited initial order covers one device family. The fixed price is agreed and paid before we start. You decide on further device families after the initial order.

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.