Terms of service

MEDAZA EUROPE, D.O.O.

TERMS OF SERVICE AND GENERAL TERMS OF PURCHASE

Effective Date: July 1st, 2026

These Terms of Service and General Terms of Purchase ("Terms") govern all purchases of medical devices, healthcare supplies, prescription-based products, and over-the-counter (OTC) health products made through the Medaza Europe, d.o.o. ("Medaza Europe," "we," "us," or "our") online platform (the "Platform") by both institutional buyers (including but not limited to veterinary clinics, medical institutions, and other authorized business purchasers) and individual end-user consumers purchasing OTC products or products pursuant to a valid medical prescription ("Buyer," "you," or "your") within the European Union and European Economic Area. By creating an account, placing an order, or otherwise using the Platform, Buyer agrees to be bound by these Terms. If Buyer does not agree to these Terms, Buyer must not use the Platform.

1. Definitions

  • "Buyer" means either: (a) an institutional entity or its authorized representative purchasing products through the Platform ("Institutional Buyer"); or (b) an individual natural person acting for purposes outside their trade, business, craft, or profession who purchases appropriate certified over-the-counter (OTC) products or prescription-required products with a valid prescription through the Platform ("Consumer Buyer").

  • "Supplier" means the independent manufacturer or distributor whose products are listed for sale on the Platform.

  • "Products" means medical devices, veterinary devices, healthcare supplies, certified OTC medical products, and prescription-authorized health products listed for sale on the Platform.

  • "Platform" means Medaza Europe's website, marketplace, and related technology services through which Products are listed and purchased.

  • "Order" means a purchase request submitted by Buyer through the Platform for one or more Products.

  • "MDR" means Regulation (EU) 2017/745 on medical devices, as amended, and any implementing or successor legislation.

  • "EUDAMED" means the European Database on Medical Devices established under the MDR.

  • "Valid Prescription" means a lawful order for a medical device or product issued by a qualified, licensed healthcare professional in accordance with applicable EU and national member state regulations.

  • "OTC Products" means non-prescription healthcare products and self-care medical devices that are appropriately certified and legally permitted for direct-to-consumer sale under applicable EU and national laws.

2. Eligibility, Accounts, and Order Authorizations

The Platform serves both institutional/business purchasers (B2B) and individual consumers (B2C) located within the European Union and European Economic Area:

  • Institutional Eligibility: Institutional Buyers represent and warrant that they are a licensed or otherwise legally authorized institutional purchaser of medical devices and healthcare supplies under applicable EU and national law, and that all information provided during registration is accurate and complete.

  • Consumer Eligibility & Prescription / OTC Rules: Consumer Buyers purchasing appropriate certified OTC products represent that they are of legal age to enter into binding contracts under their local jurisdiction. Consumer Buyers purchasing products that require a prescription represent and warrant that they possess a Valid Prescription issued by a licensed medical practitioner. Medaza Europe reserves the right to request, verify, and store documentation of a Valid Prescription prior to dispatching any prescription-required Product.

  • Credentials & Verification: Medaza Europe reserves the right to verify Buyer's credentials, licensure, prescription validity, or institutional status prior to accepting any Order, and to suspend or terminate any account found to contain inaccurate or fraudulent information. Buyer is responsible for maintaining the confidentiality of its account credentials and for all activity occurring under its account. Buyer must notify Medaza Europe promptly of any unauthorized use of its account.

3. Platform Role and Relationship of Parties

Medaza Europe, d.o.o. ("Medaza Europe") operates a technology platform that connects buyers ("Buyer") with independent suppliers and manufacturers of medical devices, healthcare supplies, and certified health products ("Supplier(s)"). Medaza Europe is not the manufacturer of any product sold through this platform. Nothing in these Terms creates a partnership, joint venture, or agency relationship between Medaza Europe and any Buyer or Supplier beyond that of the role(s) described in Section 4.

4. Regulatory Role Under the MDR

Medical devices supplied through the Platform are regulated under the MDR, which assigns distinct roles and obligations to manufacturers, authorized representatives, importers, and distributors ("economic operators"). Medaza Europe acts as both a distributor and an importer under the MDR with respect to Products supplied through this Platform, and complies with the corresponding obligations under both Article 13 (importer duties) and Article 14 (distributor duties), including:

  1. verifying that the manufacturer has affixed the CE marking and issued a valid declaration of conformity;

  2. confirming that the manufacturer has designated an EU Authorized Representative where required;

  3. verifying that the device is registered, and that Medaza Europe's own role as importer is recorded, in EUDAMED as applicable;

  4. ensuring Medaza Europe's name, registered trade name or trademark, and address are indicated on the device, its packaging, or accompanying documentation as required by Article 13;

  5. maintaining appropriate storage and transport conditions in accordance with the manufacturer's requirements; and

  6. cooperating with manufacturers, competent authorities, and other economic operators on vigilance, traceability, and recall matters.

Because Medaza Europe is the first economic operator placing certain Products on the EU market from a non-EU manufacturer, it assumes the importer's obligations in addition to, and not instead of, its distributor obligations. Where a conflict of duty could arise between these two roles, Medaza Europe's importer obligations under Article 13 take precedence.

5. Product Information and Quality Assurance

Medaza Europe performs supplier and product review procedures, including documentation and CE conformity checks, prior to listing products on this Platform, and maintains recall coordination procedures consistent with applicable MDR and national regulatory requirements. These procedures are intended to support the integrity of the Platform and compliance with applicable MDR obligations; they do not constitute an independent certification or guarantee of any product's clinical safety, performance, or fitness for a particular purpose.

Product descriptions, specifications, images, and pricing are provided for informational purposes and are subject to change without notice. Medaza Europe does not warrant that product descriptions or other content on the Platform are accurate, complete, reliable, current, or error-free, and relies on information provided by Suppliers and manufacturers for such content. Nothing on the Platform or in product listings provided to Consumer Buyers constitutes individual medical advice or diagnosis.

6. Orders and Acceptance

All Orders submitted through the Platform constitute an offer by Buyer to purchase the selected Products, subject to acceptance by Medaza Europe. Medaza Europe reserves the right to accept, reject, or cancel any Order, in whole or in part, for any reason, including but not limited to Product unavailability, pricing errors, suspected fraud, failure to verify Buyer's institutional eligibility, or failure to verify a Valid Prescription for prescription-required Products. An Order is not binding on Medaza Europe until confirmed in writing (including by email confirmation).

7. Pricing and Payment

All prices are stated in Euros (€) unless otherwise indicated.

  • For Institutional Buyers, prices are exclusive of applicable VAT and other taxes, which shall be the responsibility of Buyer unless a valid VAT exemption or reverse-charge status applies.

  • For Consumer Buyers, applicable VAT and consumer taxes will be clearly indicated and included at checkout in accordance with applicable EU destination-based VAT regulations.

Medaza Europe reserves the right to correct pricing errors at any time prior to shipment. Payment terms shall be as specified at checkout or in a separate written agreement between Medaza Europe and Buyer. Buyer agrees to pay all amounts due in accordance with the payment method and terms selected at the time of purchase.

8. Shipping, Delivery, and Risk of Loss

Shipping and delivery timeframes provided on the Platform are estimates only and are not guaranteed.

  • For Institutional Buyers, title and risk of loss for each Product shall pass to Buyer upon delivery to the carrier at the shipping origin, unless otherwise specified in writing.

  • For Consumer Buyers, risk of loss or damage passes to the Consumer Buyer only when the Consumer Buyer (or a third party designated by the Consumer Buyer) acquires physical possession of the Products, in accordance with EU consumer protection legislation.

Buyer is responsible for inspecting Products promptly upon receipt and notifying Medaza Europe of any shipping damage, shortage, or discrepancy within the timeframe specified in Medaza Europe's return policy.

9. Returns and Cancellations

Returns, exchanges, and order cancellations are subject to Medaza Europe's then-current return policy, which may vary by Supplier and Product category, including for reasons related to sterility, regulatory handling requirements, or Supplier-specific restocking terms.

  • Institutional Buyers: As Institutional Buyers are business entities and not consumers, statutory consumer distance-selling withdrawal rights under EU law do not apply to Orders placed by Institutional Buyers under these Terms.

  • Consumer Buyers: Consumer Buyers purchasing eligible OTC products or non-exempt medical goods generally have a statutory 14-day right of withdrawal under EU Directive 2011/83/EU. However, in accordance with applicable EU consumer legislation, the right of withdrawal does not apply to:

    1. Products sealed for health protection or hygiene reasons once unsealed after delivery;

    2. Prescription-required medical products and custom-made devices; or

    3. Products liable to deteriorate or expire rapidly.

10. Disclaimer of Warranties

EXCEPT AS EXPRESSLY STATED IN WRITING BY MEDAZA EUROPE, ALL PRODUCTS ARE SOLD "AS IS" AND MEDAZA EUROPE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT, EXCEPT TO THE EXTENT SUCH WARRANTIES CANNOT BE EXCLUDED UNDER APPLICABLE MANDATORY LAW. Any manufacturer warranty applicable to a Product is passed through to Buyer to the extent permitted by the manufacturer, and Buyer's exclusive remedy for defective Products is against the manufacturer or its EU Authorized Representative under that warranty, without prejudice to any mandatory legal guarantees or obligations Medaza Europe cannot lawfully disclaim in its capacity as importer under the MDR or under mandatory EU consumer protection laws.

11. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MEDAZA EUROPE'S TOTAL LIABILITY ARISING OUT OF OR RELATED TO ANY PURCHASE SHALL NOT EXCEED THE AMOUNT PAID BY BUYER FOR THE SPECIFIC PRODUCT GIVING RISE TO THE CLAIM. IN NO EVENT SHALL MEDAZA EUROPE BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, LOST DATA, OR BUSINESS INTERRUPTION, EVEN IF MEDAZA EUROPE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. This limitation applies regardless of the theory of liability (contract, tort, negligence, strict liability, or otherwise) and shall survive any termination of these Terms.

Nothing in these Terms excludes or limits liability that cannot be excluded or limited under mandatory EU or national law, including liability for death or personal injury caused by negligence, liability arising from Medaza Europe's own non-compliance with its Article 13 importer obligations, mandatory statutory guarantees owed to Consumer Buyers, or liability under applicable product liability legislation implementing Directive 85/374/EEC (as amended or replaced).

12. Buyer's Acknowledgment of Risk Allocation

By purchasing through this Platform, Buyer acknowledges and agrees that:

  1. Medaza Europe acts as both distributor and importer under the MDR, as described in Section 4, and is not the manufacturer;

  2. Product safety, performance, clinical suitability, and CE conformity are the responsibility of the manufacturer; Medaza Europe, in its capacity as importer, is responsible for verifying — but not independently certifying — conformity documentation prior to placing Products on the EU market;

  3. Buyer (and in the case of Consumer Buyers, in consultation with their qualified healthcare professional) is responsible for independently verifying that any Product is appropriate for its intended use prior to use;

  4. Any claims regarding product defects, malfunction, or injury arising from product use should be directed to the manufacturer or its EU Authorized Representative in the first instance, without prejudice to any mandatory liability of economic operators under the MDR, mandatory consumer laws, or applicable product liability law.

13. Buyer Indemnification

Buyer agrees to indemnify, defend, and hold harmless Medaza Europe, its officers, employees, and agents from and against any claims, damages, losses, and expenses (including reasonable legal fees) arising out of: (a) Buyer's misuse or alteration of a Product; (b) Buyer's failure to follow manufacturer instructions, labeling, valid prescription guidelines, or applicable clinical protocols; (c) Buyer's violation of these Terms or applicable law; or (d) any claim brought by a third party (including patients, animal owners, or third-party end-users) arising from Buyer's use or secondary distribution of a Product purchased through the Platform.

14. Manufacturer Obligations (Cross-Reference)

Separately, Medaza Europe requires manufacturers and Suppliers listing products on this Platform to provide contractual assurances regarding CE conformity, EU Authorized Representative arrangements (where applicable), cooperation with Medaza Europe's Article 13 import-verification obligations, and indemnification of Medaza Europe for claims arising from product defects, regulatory non-compliance, or inaccurate product documentation, pursuant to Medaza Europe's Manufacturer/Supplier Agreement. This indemnification runs from the manufacturer or Supplier to Medaza Europe and does not create any direct right of action by Buyer against the manufacturer or Supplier under these Terms.

15. Recalls and Vigilance

In the event of a manufacturer-initiated or competent-authority-initiated recall or field safety corrective action, Medaza Europe will make commercially reasonable efforts to notify affected Buyers (including reaching out directly to Consumer Buyers where traceability records exist) and cooperate with the manufacturer, its EU Authorized Representative, and relevant competent authorities on remedy procedures, consistent with its obligations as importer and distributor under the MDR. Medaza Europe's role in recall or vigilance coordination does not expand its liability beyond that stated in Section 11.

16. Buyer's Regulatory Responsibilities

Buyer is solely responsible for ensuring that its purchase, possession, and use of any Product complies with all applicable EU, national, and local laws and regulations, including maintaining valid prescriptions (for consumers) or any licensure, permitting, or registration requirements applicable to Buyer's own business, practice, or persona. Nothing on the Platform constitutes legal, regulatory, or personal clinical advice, and Consumer Buyers should always consult qualified healthcare professionals regarding medical conditions or treatment choices.

17. Data Protection

Medaza Europe processes personal data in accordance with Regulation (EU) 2016/679 (General Data Protection Regulation) and its published Privacy Policy, available on the Platform's Privacy Policy page. By using the Platform, Buyer acknowledges that its account, order, and prescription/health verification data (where applicable) will be processed securely as described therein.

18. Intellectual Property

All content on the Platform, including text, graphics, logos, product images, and software, is the property of Medaza Europe or its licensors and is protected by applicable intellectual property laws. Buyer is granted a limited, non-exclusive, non-transferable license to access and use the Platform solely for its intended purpose of evaluating and purchasing Products. No other rights are granted.

19. Force Majeure

Medaza Europe shall not be liable for any delay or failure to perform its obligations under these Terms resulting from causes beyond its reasonable control, including but not limited to acts of God, natural disasters, pandemic, war, terrorism, labor disputes, governmental action, customs delays, carrier delays, or supply chain disruptions affecting Suppliers or manufacturers.

20. Term and Termination

These Terms remain in effect for as long as Buyer maintains an account or uses the Platform. Medaza Europe may suspend or terminate Buyer's account or access to the Platform at any time, with or without cause, including for violation of These Terms or submission of invalid/fraudulent prescriptions. Sections that by their nature should survive termination — including Sections 10, 11, 13, 14, and 22 — shall survive any termination of These Terms.

21. Modifications to These Terms

Medaza Europe reserves the right to modify these Terms at any time by posting the revised Terms on the Platform. Changes will apply prospectively to Orders placed after the effective date of the revised Terms. Buyer's continued use of the Platform following any such change constitutes acceptance of the revised Terms.

22. Governing Law and Dispute Resolution

These Terms are governed by the laws of the Republic of Slovenia and, where applicable, mandatory EU law, without regard to conflict-of-law principles.

  • For Institutional/Business Buyers: Any dispute arising out of or relating to these Terms shall be resolved through binding arbitration seated in Ljubljana, Slovenia, administered under the arbitration rules of the Ljubljana Arbitration Centre at the Chamber of Commerce and Industry of Slovenia, conducted by a single arbitrator. Each party shall bear its own legal costs, except as the arbitrator may otherwise award. The arbitrator's award shall be final and binding. Any claim shall be brought only in a party's individual capacity, and not as a plaintiff or class member in any purported class, collective, consolidated, or representative proceeding. Notwithstanding the foregoing, either party may seek injunctive or other equitable relief in a court of competent jurisdiction at any time where necessary to prevent irreparable harm, including in connection with a product recall, safety matter, or protection of intellectual property rights, without first pursuing arbitration.

  • For Consumer Buyers: The arbitration provisions above do not apply to Consumer Buyers. Consumer Buyers retain the right to bring a claim before the competent courts of their country of habitual residence, without prejudice to any mandatory consumer protections under applicable EU or national law that cannot be limited or waived by agreement. Consumer Buyers may also refer a dispute to the applicable national consumer alternative dispute resolution body or the European Commission's Online Dispute Resolution (ODR) framework.

Nothing in this Section limits any right or protection that cannot be excluded or restricted under mandatory EU or national consumer protection law.

23. Notices

Any notice required or permitted under these Terms shall be in writing and delivered by email to the address associated with Buyer's account, or to Medaza Europe via the official contact email published on the Platform. Notices are deemed given upon transmission, provided no delivery failure notice is received.

24. Entire Agreement

These Terms, together with any applicable Order confirmation, Supplier-specific warranty terms, and Medaza Europe's published policies referenced herein, constitute the entire agreement between Buyer and Medaza Europe with respect to the subject matter hereof, and supersede all prior or contemporaneous agreements, representations, or understandings, whether written or oral.

25. Severability

If any provision of these Terms is held unenforceable, the remaining provisions shall remain in full force and effect, and the unenforceable provision shall be modified to the minimum extent necessary to make it enforceable.

26. Assignment

Buyer may not assign or transfer its rights or obligations under these Terms without Medaza Europe's prior written consent. Medaza Europe may assign these Terms in connection with a merger, acquisition, or sale of substantially all of its assets.

27. Waiver

No failure or delay by Medaza Europe in exercising any right under these Terms shall operate as a waiver of that right, nor shall any single or partial exercise of a right preclude any other or further exercise of that right.