UDIFlow Medical Storage

Terms of Service

1. Contracting Parties and Scope

The provider of the UDIFlow service is XXXXX d.o.o., XXXX, 3000 XXXX, Slovenia, company registration number XXXXXXXXX, VAT ID SIXXXXXX, e-mail info^udiflow.eu (hereinafter: Provider).

These terms and conditions apply exclusively to business users. By accepting, the Client confirms that he/she is ordering the service in the context of performing his/her commercial, professional or other gainful activity and not as a consumer. These terms and conditions, the order form, the applicable price list, the MSA, the SLA and the DPA together form a contract.

UDIFlow is a stand-alone marketable software product for the recording, traceability, receipt, issuance and related documentation of medical devices. It is not a medical device, nor is it software support for a medical device and does not provide clinical, diagnostic or regulatory decisions. The Client remains responsible for its legal, regulatory, quality and strict obligations.

2. Conclusion, duration and trial period

The contract is concluded by written confirmation of the order by the Provider or by activation of a paid subscription period. The usual period is one year and is paid in advance. Automatic renewal only applies if expressly stated in the order form or price list. The Provider sends a notice of impending expiration at least one month before the end of the paid period.

The trial period lasts one month, when so agreed in writing. If the Subscriber does not confirm the subscription after the trial period, access is terminated; the data is handled according to Article 7.

A subscription concluded for a fixed period cannot be terminated before its expiration due to the Subscriber’s decision. This does not limit mandatory rights that cannot be excluded contractually or rights due to material breaches by the other party.

3. Price, invoices and late payment

Prices are in EUR and are published in the valid price list on the UDIFlow website or in the offer. The price list or invoice clearly states whether VAT is included. Unless otherwise agreed in writing, payment of the subscription fee is in advance.

The invoice payment deadline is 5 working days from the date of issue of the invoice. A working day is a working day in Slovenia, excluding Saturdays, Sundays and Slovenian national holidays. In the event of delay, the Provider may send a reminder. If the invoice is not paid within 10 working days after the due date, the Provider may temporarily suspend access to the service until the overdue amounts have been settled.

Suspension means that normal login and application access is disabled; it does not mean that ownership of the data is transferred to the Provider. The Subscriber may request export during the 30-day withdrawal period via an authorized person on omfp^udiflow.eu. If payment is not settled within this period or the contract is otherwise terminated, the data will be deleted in accordance with Article 7.

4. User Accounts and Permitted Use

The Subscriber shall designate authorized users and administrators and shall be responsible for their actions, the accuracy of the information provided, and the security of the credentials. Accounts may not be shared, security measures may not be bypassed, vulnerabilities may not be tested without written permission, malicious content may not be uploaded, or the services may not be used illegally.

The Provider may limit or temporarily block an account when necessary to protect the service, other subscribers, data, or due to reasonable suspicion of misuse. Where circumstances permit, the Subscriber shall be notified thereof.

5. Data, Documents, and Intellectual Property

The Subscriber retains all rights to the data it enters, creates, or uploads to the service (Subscriber Data). The Subscriber grants the Provider a limited right to process such data solely for the purpose of providing the service, support, security, backups, and compliance with legal obligations.

The Provider’s software, documentation, trademarks, and other rights shall remain the property of the Provider or its licensors. The Subscriber is granted a non-transferable, non-exclusive right to use the Service for its internal business needs during the term of the applicable subscription.

6. Support, Availability and Service Changes

Support and availability targets are described in the SLA. The Provider may improve, maintain or change the Service, without any reasonable cause, and shall not significantly reduce the subscribed functionality during the period already paid for.

7. Export, deletion and retention of data

One standard full data export per year is included in the annual subscription. Upon termination of the subscription, the standard export is free of charge at the justified request of the Subscriber. Extraordinary or specially adapted exports may be charged according to the price list, if the Subscriber confirms this in advance.

The Subscriber may at any time request the deletion of their data free of charge through an authorized person. After termination of the contract, a suspension that is not lifted, or a valid request for deletion, the Provider will permanently delete the Subscriber’s data no later than one month, unless the law requires longer retention. User data is not accessible in the application during this time; export is only possible via a verified authorized request. Data in backup copies is deleted within the same maximum period, except for legal exceptions.

Legally required accounting and tax records may be stored for as long as required by law and are not part of normal functional access in UDIFlow.

Mandatory portability rules. If Chapter VI of Regulation (EU) 2023/2854 (Data Act) applies to UDIFlow, the Client shall, notwithstanding any other provisions, have the right to initiate a migration to another provider or its own infrastructure by giving a written notice not exceeding two months. The Provider shall cooperate in good faith, enable the export of all exportable data and digital assets without undue delay and within a maximum mandatory transition period of 30 calendar days. After the end of the transition period, a minimum of 30 calendar days shall be available for data retrieval; only after that shall the data be deleted if the migration is successful. These mandatory rights shall prevail over the provisions on fixed subscription periods, suspension and regular one-year export to the extent required by law.

8. Confidentiality and Data Protection

Each party shall protect the confidential information of the other party and use it only for the performance of the contract. The processing of the Client’s personal data is governed by the DPA. The Privacy Policy applies to data about persons with whom the Provider communicates as an independent controller (e.g. contact persons, support, billing and security).

9. Liability

To the maximum extent permitted by law, the Provider’s total liability for all claims related to the contract shall not exceed the amount of subscription fees actually paid by the Subscriber for the service in the 12 months prior to the claim arising. The Provider is not liable for indirect damage, lost profits, loss of revenue, reputation, business opportunity or data, unless liability cannot be excluded.

The limitations do not apply to intent, gross negligence or to liability that cannot be limited or excluded by mandatory regulations. The Subscriber is responsible for its own regulatory decisions, inputs, users, network and security of its devices.

10. Termination and consequences

Either party may terminate the contract for a material breach if the other party fails to remedy the breach within a reasonable period of time specified in writing, where remediation is possible. The Provider may also terminate the contract if the payment delay following suspension is not remedied within 30 days.

Upon termination, the right of use shall terminate. Article 7 shall continue to apply to export, deletion and statutory storage.

11. Law, jurisdiction and language

The law of the Republic of Slovenia shall apply to the contract, without any rules on conflict of laws. The court with substantive jurisdiction in Slovenia shall have exclusive jurisdiction for disputes. The Slovenian version shall be the only binding one. The English texts are merely an informative translation and in the event of any discrepancy, the Slovenian version shall prevail.

12. Changes to the terms and conditions and contact

The Provider may change the terms and conditions for future subscription periods or when required by law, security or service. It shall notify the Subscriber of a material change at least 30 days in advance, where reasonably possible. For questions and official notifications, please use info^udiflow.eu.