Terms of Service

1. What the Service is, and what it is not

RunaReg is a workspace for preparing, reviewing and defending medical device regulatory documentation, including technical documentation under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It combines deterministic rule checks, retrieval from a curated regulatory knowledge base, and AI-assisted drafting, and it records an audit trail of the work performed.

• RunaReg is not a Notified Body, a competent authority, or a law firm, and its outputs are not regulatory, legal or medical advice. Outputs are advisory and must be reviewed and approved by the Customer's qualified personnel, including the person responsible for regulatory compliance, before any use in a formal submission.
• RunaReg does not submit anything to EUDAMED or to any authority, does not manage UDI registrations, and does not replace the Customer's own submission workflow. Where the Service prepares data for EUDAMED, the Customer performs the submission.
• Determinations of device classification, applicability, conformity and readiness shown in the Service are recorded on the basis of the information the Customer supplied. Responsibility for the correctness of that information and for every regulatory decision remains with the Customer.

2. Accounts and tenants

• Each Customer receives an isolated tenant. Users are provisioned by RunaReg or by the Customer's administrator; there is no public self-registration during the pilot phase.
• The Customer is responsible for keeping credentials confidential, for assigning roles appropriately (including signatory roles), and for all activity under its accounts.
• The Customer must notify RunaReg without undue delay of any suspected unauthorised access.

3. Customer content and intellectual property

• The Customer retains all rights in the documents, data and other content it uploads or creates in the Service ("Customer Content"). The Customer grants RunaReg a licence to host, process, index and display Customer Content solely to provide, secure and support the Service.
• RunaReg retains all rights in the Service, its software, its regulatory knowledge base and its templates. Documents generated for the Customer may be used by the Customer without restriction once exported.
• RunaReg does not use Customer Content to train machine-learning models. AI providers used by the Service are contractually restricted to processing Customer Content only to return a result to the Service.

4. AI-assisted features

• Where the Service drafts or proposes text, it marks the origin of that text (deterministic template, AI draft, or human edit) and records the sources it relied on. Every AI-drafted output requires human review and approval inside the Service before it can be exported as a regulated document.
• AI outputs may contain errors. The Customer must not rely on any output without reviewing it against the underlying sources.
• The Service records a timestamped audit trail of drafting, review, approval and export actions. This audit trail is part of the Customer's regulated record and is retained as described in the Privacy Policy.

5. Acceptable use

• The Customer must not use the Service to process content it has no right to process, to attempt to access another tenant's data, to probe or overload the Service, or to reverse engineer it.
• The Customer must not upload personal data beyond what is necessary for the regulatory documentation being prepared, and must not upload special categories of personal data (such as patient health data) unless a separate written agreement covers it.

6. Data protection

RunaReg processes personal data as a processor on the Customer's behalf under the Data Processing Agreement, and as a controller for account and security data as described in the Privacy Policy. Both documents form part of these Terms.

7. Availability and support

• During the pilot phase, RunaReg is provided without a contractual service-level commitment. Support hours, response targets and what is monitored automatically are described in the pilot support expectations shared with the Customer.
• RunaReg may modify or suspend features with reasonable notice, and may suspend access immediately where necessary to protect the Service or other customers.

8. Fees

Fees, invoicing and payment terms are set out in the Customer's pilot or order agreement. Where no fee is agreed, the pilot is provided free of charge for the agreed period.

9. Warranties and disclaimers

RunaReg will provide the Service with reasonable skill and care. Except as expressly stated, the Service is provided "as is". RunaReg does not warrant that any output is accurate, exhaustive or sufficient for any submission, audit or certification, and does not warrant that a Notified Body or authority will accept any document prepared with the Service.

10. Liability

To the extent permitted by law, RunaReg's aggregate liability under these Terms is limited to the fees paid by the Customer in the twelve months preceding the claim, and RunaReg is not liable for indirect or consequential loss, loss of profit, or regulatory sanctions arising from the Customer's use of outputs. Nothing limits liability for wilful misconduct, gross negligence, death or personal injury, or any liability that cannot be limited by law. [Counsel to confirm against the governing law chosen below.]

11. Term and termination

• These Terms apply for as long as the Customer has an account. Either party may terminate on [30] days' written notice; RunaReg may terminate immediately for material breach that is not cured within [14] days of notice.
• On termination the Customer may export its Customer Content for [30] days, after which RunaReg deletes it, subject to the retention of the audit trail and backups described in the Privacy Policy.

12. Changes to these Terms

RunaReg may update these Terms with at least [30] days' notice by email to the Customer's administrator. Continued use after the effective date constitutes acceptance. The version date at the top of this page identifies the current text.

13. Governing law and disputes

These Terms are governed by the laws of [governing jurisdiction], and the courts of [venue] have exclusive jurisdiction, without prejudice to mandatory consumer or data-protection law. [Counsel to select jurisdiction consistent with the legal entity.]

14. Contact

[RunaReg legal entity name], [registered address]. Email: hello@runareg.com.