EUDAPrep disclaimers — v1.0.0

EUDAPrep is a document-processing tool that helps you prepare an EUDAMED-schema-valid XML for your medical device registration.

Important — please understand before you start:

• You submit, we don't. EUDAPrep does not transmit anything to EUDAMED on your behalf. You download the XML and submit it through the EU Commission's own EUDAMED interface.
• Suggestions, not advice. This tool suggests field values and code mappings based on your uploaded documents. It is not regulatory advice. All suggestions are presented for your review before being included in your submission.
• Manufacturer accountability is unchanged. The manufacturer is responsible for the accuracy of all data submitted to EUDAMED (MDR Articles 10(7), 27, 29, 31). The person responsible for regulatory compliance (MDR Article 15(3)) ensures that the manufacturer's internal processes meet these obligations. EUDAPrep does not assume any part of that responsibility.
• AI is in use. Some features — document text extraction, code mapping, translation, text formatting — use generative AI. AI-generated outputs are marked in the interface for your review.

By clicking I understand and accept, you confirm you have read the above and accept these terms. This acknowledgement is recorded with your account, the version of this notice you accepted, the time of click, your IP address, and your browser identifier (user-agent). This record is retained for ten (10) years from the date of acknowledgement for the establishment, exercise, or defence of legal claims (GDPR Art. 17(3)(e)). See our Privacy Policy for full details on lawful basis, your rights, and how to contact our DPO.

You are about to generate the EUDAMED XML for this submission and download it.

By proceeding, you confirm:

• You have reviewed all suggestions and field values in this submission.
• You are responsible for the data you submit to EUDAMED.
• This submission will be locked as immutable for audit purposes after export. To make changes after export, you must duplicate the submission, which counts as a separate export.

The XML will be downloaded to your device. To register the device with EUDAMED, you must upload the XML through the EU Commission's own EUDAMED interface — EUDAPrep does not transmit on your behalf.