Legal notice

MEDAZA EUROPE, D.O.O. — GENERAL LEGAL NOTICES

Effective Date: July 1st, 2026

This page contains additional legal notices applicable to your use of the Medaza Europe, d.o.o. ("Medaza Europe") platform, supplementing our Terms of Service, Privacy Policy, and Shipping Policy.

1. Regulatory Status of Products — Human-Use and Veterinary Products

Medaza Europe distributes both human-use and veterinary-use medical devices, which are subject to materially different regulatory frameworks within the European Union:

  • Human-use Products. Human-use devices distributed through this Platform are subject to Regulation (EU) 2017/745 (the "MDR") and must bear valid CE marking and a corresponding declaration of conformity issued by the manufacturer. Medaza Europe's role and obligations as distributor and importer under the MDR with respect to human-use Products are described in our Terms of Service.
  • Veterinary-use Products. Veterinary-use devices are excluded from the scope of the MDR and are not subject to CE marking as medical devices under EU law. Instead, veterinary devices fall under general EU product safety law (including the General Product Safety Regulation) and, in some cases, additional national rules that vary by country, as there is no dedicated EU-wide regulatory framework specific to veterinary medical devices. Notwithstanding the absence of a mandatory CE-marking or EU-wide veterinary device framework, Medaza Europe requires that all veterinary-use Products distributed through this Platform be manufactured under a facility holding ISO 13485 certification for medical device quality management systems, as a matter of Medaza Europe's own quality assurance policy.
  • Human-Use vs. Veterinary-Only Labeling. Buyer is responsible for confirming whether a given Product is labeled and intended for human use or veterinary use only prior to purchase, and for using each Product solely in accordance with its labeled intended use. Products labeled for veterinary use only are not intended, evaluated, or approved for use on human patients, and do not carry CE marking as a human medical device.

2. Country Distribution Notice

Medaza Europe ships Products only to buyers located in EU countries where Medaza Europe has confirmed that its MDR importer/distributor role, VAT registration or applicable postponed accounting arrangement, and any additional national-level registration or notification requirements are in place for that country and product category. Medaza Europe does not ship to a country on the basis of an assumed or unconfirmed regulatory or tax position. If a country's requirements have not yet been confirmed as satisfied, Medaza Europe will not accept or will cancel Orders shipping to that country until the applicable requirements have been confirmed. Medaza Europe continually expands the list of countries in which distribution is confirmed, and Buyer's ability to complete an Order to a given country reflects Medaza Europe's current confirmed status for that country at checkout. Buyer remains independently responsible for confirming that its own receipt, possession, and use of any Product complies with the requirements of its own country.

3. VAT and Import Position

Medaza Europe's role as Importer of Record, its VAT invoicing and reverse charge practices, and the allocation of duties and import costs are described in detail in our Shipping Policy. This Notice does not modify those terms.

4. Country of Origin and Import Sourcing

Products distributed through this Platform are sourced from manufacturers located in multiple countries, including but not limited to China, South Korea, and Canada, as well as other countries as Medaza Europe's Supplier base evolves. Medaza Europe undertakes the import compliance procedures described in our Shipping Policy and Terms of Service, including country-specific customs, tariff classification, and MDR import verification requirements as applicable to each country of origin and Product type. Country-of-origin information for a specific Product is available upon request.

5. Export Control and Trade Sanctions Notice

Certain Products available on this Platform may be subject to EU dual-use export control rules under Regulation (EU) 2021/821 and to EU restrictive measures (sanctions) regimes, as well as applicable national export control laws of EU countries. Buyer represents and warrants that it is not located in, under the control of, or a national or resident of any country or region subject to comprehensive EU or UN trade sanctions, and is not identified on any applicable EU or national restricted party list. Buyer agrees not to export, re-export, or transfer any Product purchased through this Platform in violation of applicable export control or sanctions laws, and is solely responsible for obtaining any export or import licenses or authorizations required for its own subsequent use, resale, or transfer of a Product.

6. No Medical or Clinical Advice

Nothing on this Platform, including product descriptions, specifications, or customer support communications, constitutes medical, veterinary, clinical, or professional advice. Content on this Platform is provided for general informational purposes to support institutional and, where applicable, prescription-verified consumer purchasing decisions, and does not substitute for the independent professional judgment of a licensed practitioner regarding the appropriateness of any Product for a specific patient, animal, or clinical situation.

7. Intellectual Property and Copyright Notice

All trademarks, service marks, trade names, logos, and copyrighted content appearing on this Platform are the property of Medaza Europe, its licensors, or the respective Suppliers and manufacturers whose products are listed, and are protected under applicable EU and international intellectual property laws. Nothing on this Platform grants Buyer any right, license, or interest in any such intellectual property except the limited license to use the Platform described in our Terms of Service. If Buyer believes content on this Platform infringes its intellectual property rights, Buyer may submit a notice to Medaza Europe at contacteurope2@medaza-platform.com, including sufficient detail to identify the allegedly infringing material and a good-faith statement of the basis for the claim.

8. Electronic Communications and Records

By creating an account or placing an Order, Buyer consents to receive communications from Medaza Europe electronically, including order confirmations, shipping notifications, regulatory or vigilance notices, and changes to this Notice or our Terms of Service, consistent with applicable EU e-commerce and consumer information requirements. Buyer agrees that electronic communications satisfy any legal requirement that such communications be in writing, to the extent permitted by applicable law.

9. Accessibility

Medaza Europe is committed to providing a Platform that is accessible to all users, consistent with the European Accessibility Act and applicable national implementing legislation. If Buyer encounters an accessibility barrier while using this Platform, Buyer may contact Medaza Europe at contacteurope2@medaza-platform.com to report the issue, and Medaza Europe will make reasonable efforts to address it.

10. Third-Party Suppliers and Manufacturers

Medaza Europe works with independent Suppliers and manufacturers to list Products on this Platform. Medaza Europe's relationship with any given Supplier or manufacturer does not constitute an endorsement of that party's other products, services, or business practices beyond the specific Products listed, and Buyer's dealings with any Supplier or manufacturer outside the scope of a Platform-facilitated Order are solely between Buyer and that party.

11.Product Liability Insurance and Supplier Indemnification

Medaza maintains active product liability & cyber security insurance coverage applicable to its distribution and cyber activities. Additionally, Medaza maintains indemnification agreements with its Suppliers and manufacturers, under which Suppliers and manufacturers are contractually obligated to indemnify Medaza for claims arising from product defects, regulatory non-compliance, or inaccurate product documentation, as further described in our Terms of Service. These arrangements support Medaza's risk management practices but do not expand Medaza's liability beyond what is expressly stated in our Terms of Service, do not constitute a warranty or guarantee of any Product's safety or performance, and do not create any direct right of action by Buyer against Medaza's insurer or against any Supplier or manufacturer under these arrangements.

12. Governing Law and Dispute Resolution

This Notice is governed by the laws of the Republic of Slovenia and applicable mandatory EU law, and is subject to the governing law, dispute resolution, and limitation of liability provisions set out in our Terms of Service, which apply equally to the notices in this document.

13. Updates to This Notice

Medaza Europe may update this Notice from time to time to reflect changes in applicable law or Medaza Europe's business practices, including as Medaza Europe's country distribution status, product catalog, or Supplier country footprint changes. The "Effective Date" above will be updated accordingly, and continued use of the Platform after such changes constitutes acceptance of the revised Notice.

 

14. Data Breach Notification

In the event of a personal data breach, Medaza Europe will assess the breach in accordance with Articles 33 and 34 of the General Data Protection Regulation. Where the breach is likely to result in a risk to the rights and freedoms of natural persons, Medaza Europe will notify the competent supervisory authority without undue delay and, where feasible, within 72 hours of becoming aware of the breach, providing the information required under Article 33(3) to the extent known at that time. Where the breach is likely to result in a high risk to the rights and freedoms of affected individuals, Medaza Europe will also communicate the breach to those individuals without undue delay, describing in clear and plain language the nature of the breach and the measures taken or proposed to address it, unless an exemption under Article 34(3) GDPR applies (for example, where appropriate technical protection measures, such as encryption, render the affected data unintelligible to any unauthorized party). Notification to individuals will be provided by email to the address associated with Buyer's account, or by other means reasonably calculated to reach affected individuals where email is not available or appropriate.