Terms of service

“We,” “us,” or “Artifakt” refers to the legal entity operating the Artifakt service (registered office in the European Union; details available on request from legal@artifakt.cc).

“You” or “the customer” refers to the natural or legal person who creates an account. Where the account is created on behalf of a company (a medical-device manufacturer using Artifakt to draft regulatory documentation), the person who accepts these terms warrants that they have authority to bind that company.

Artifakt is a software-as-a-service product that helps medical- device manufacturers draft EU MDR (Regulation 2017/745) technical documentation. It uses large language models, vector-search retrieval, OCR, and machine translation to assemble draft sections from your evidence and from a public regulatory corpus.

The drafts are aids for a human regulatory team, not regulatory submissions. Every drafted section is marked “AI DRAFT — verify before submission.” You remain responsible for verifying, editing, and signing off on every document you submit to a Notified Body.

Under EU MDR Article 10, the manufacturer is responsible for the technical documentation of each device they place on the market. Artifakt is a drafting tool you use — using it does not transfer any portion of that responsibility to us. Specifically:

• You are responsible for the accuracy of the device data and evidence you upload. The assistant cannot detect factually incorrect inputs.
• You are responsible for verifying every regulatory citation, every claim, every test reference, every standard version, and every clinical assertion the assistant produces before any submission. The assistant’s output may contain errors and should be treated as a first-pass draft.
• You are responsible for any submission you make to a Notified Body, regulatory authority, or third party — irrespective of whether or how Artifakt contributed to its drafting.
• You must retain a qualified person responsible for regulatory compliance (PRRC, MDR Article 15) within your organisation.

You agree not to:

• Use the service to generate documentation for devices that fall outside the scope we support (the pilot covers EU MDR Class I and Is/Im/Ir devices — Class IIa+ and IVDR are out of scope).
• Misrepresent AI-assisted output as fully human-authored where a regulator, contracting party, or auditor requires that disclosure.
• Upload material you do not have the right to process, including another manufacturer’s confidential IFU or test data.
• Attempt to extract the regulatory corpus, system prompts, or other proprietary content of the service through prompt injection or other means.
• Probe the service for vulnerabilities except via a coordinated disclosure to security@artifakt.cc (we welcome coordinated disclosure).
• Use the service to process personal data of natural persons in categories listed in Article 9 GDPR (health data of identifiable patients, etc.) — Artifakt is not currently configured for Article 9 special-category processing.

Your content stays yours. You retain ownership of the IFU, device profile, drafts, gap notes, and attachments you produce or upload. You grant us a limited, non-exclusive licence to process that content for the sole purpose of providing the service to you. We do not use your content to train models and we do not relicense your content to other customers.

The service is ours. The application code, the regulatory corpus we have indexed, the orchestrator and worker prompts, the section templates, and the assembled work-flow are our intellectual property. Nothing in these terms grants you a licence to those except through use of the service.

During the pilot, pricing is set out in the bilateral pilot agreement signed alongside these terms. Outside of a pilot agreement, list pricing is published at artifakt.cc/pricing (page may not yet exist; contact sales@artifakt.cc in the interim).

Our handling of your personal data is described in our privacy policy and codified in a separate data-processing agreement (DPA) we sign with each business customer. The DPA names every subprocessor and pins residency to the EU.

We aim for 99% monthly availability during the pilot phase but do not yet commit to a contractual service-level agreement (SLA). Scheduled maintenance is announced via email at least 24 hours in advance.

Support questions go to support@artifakt.cc. We commit to first-response within one business day for pilot customers.

The service is provided “as is” for the pilot phase. We make no warranty that the drafts produced are fit for submission to a particular Notified Body, that they comply with any specific harmonised standard, that they are free of factual or regulatory errors, or that they are uninterrupted or error-free.

This disclaimer does not limit any consumer rights that apply by mandatory law in your jurisdiction.

To the maximum extent permitted by law, neither party is liable to the other for indirect or consequential damages (lost profit, lost goodwill, regulatory fines arising from a submission, etc.).

Our aggregate liability for direct damages is capped at the fees you paid us in the twelve months preceding the event giving rise to the claim, or €1,000 if no fees have been paid. This cap does not apply to liability that cannot be excluded by law (gross negligence, willful misconduct, infringement of intellectual property).

You may terminate your account at any time via Settings → Delete my account. We may suspend or terminate your account if you materially breach these terms or the acceptable-use clause, giving you a reasonable opportunity to cure where possible.

On termination, your data is erased per the GDPR Article 17 flow described in the privacy policy. You may export your data beforehand via Settings → Export my data.

We monitor the EU AI Act (Regulation 2024/1689) and the obligations it places on providers of AI systems used in the medical-device domain. We will publish a transparency and human- oversight disclosure (AI Act Article 13 / Article 14) ahead of the deadlines applicable to our service. If the disclosure materially affects how you use Artifakt we will communicate the changes by email at least 30 days in advance.

These terms are governed by the law of the EU member state in which we are registered, with non-exclusive jurisdiction of the courts of that state. This does not deprive consumer customers of the protection of mandatory consumer-law provisions in their country of residence.

We may update these terms; material changes are announced by email at least 30 days in advance. Continued use of the service after the effective date constitutes acceptance.

Legal questions: legal@artifakt.cc.