Terms of Use

1. Introduction

Welcome to IVDR.net ("we," "our," or "us"). These Terms of Service govern your access to and use of the IVDR.net website (https://ivdr.net) and the digital compliance templates, resources, and services we offer. IVDR.net is operated by B10TECH Biyoteknoloji Sanayi ve Ticaret Limited Şirketi, a company registered in Turkey.

By accessing our website or purchasing our digital products, you agree to be bound by these Terms. If you do not agree to these Terms, please do not use our services or purchase our products.

2. Digital Products and Licensing

Our products consist of digital downloadable compliance templates (provided in formats such as PDF, DOCX, HTML, and Markdown) designed to assist with EU In Vitro Diagnostic Regulation (IVDR) compliance.

2.1 License Grant

Upon purchase, we grant you a non-exclusive, non-transferable, revocable license to use the downloaded templates for your organization's internal regulatory compliance purposes. You may modify, adapt, and integrate these templates into your organization's Quality Management System and technical documentation.

2.2 Restrictions

You are strictly prohibited from:

• Reselling, sublicensing, or distributing the templates to third parties.
• Publishing the templates publicly on the internet or any open network.
• Using the templates to create a competing product or service.
• Sharing the templates with other corporate entities, even if affiliated, without purchasing additional licenses.

3. Disclaimer of Warranties and Liability

The templates and resources provided on IVDR.net are for informational and educational purposes only. They are designed to serve as a starting point for your compliance documentation.

No Legal Advice: Our products do not constitute legal or regulatory advice. The purchase and use of our templates do not guarantee compliance with the EU IVDR or any other regulatory framework. You are solely responsible for ensuring that your final documentation meets all applicable regulatory requirements and is appropriate for your specific medical devices.

To the maximum extent permitted by law, B10TECH Biyoteknoloji Sanayi ve Ticaret Limited Şirketi disclaims all warranties, express or implied, including fitness for a particular purpose. We shall not be liable for any direct, indirect, incidental, or consequential damages arising from the use or inability to use our products, including regulatory rejections, fines, or business interruptions.

4. Intellectual Property

All content on the IVDR.net website, including but not limited to text, graphics, logos, and the digital templates themselves, is the exclusive property of B10TECH Biyoteknoloji Sanayi ve Ticaret Limited Şirketi and is protected by international copyright and intellectual property laws. Your purchase grants you a license to use the templates as described in Section 2, but does not transfer ownership.

5. Payments and Delivery

All prices are listed in Euros (EUR) unless otherwise specified. Payment processing is handled securely through our authorized payment provider (iyzico). Upon successful payment, you will receive an email with a link to download your purchased digital products. Delivery, return and cancellation terms are set out in our Delivery, Returns & Cancellation Policy and the Distance Sales Agreement.

6. Governing Law and Jurisdiction

These Terms of Service shall be governed by and construed in accordance with the laws of Turkey, without regard to its conflict of law provisions. Any disputes arising under or in connection with these Terms shall be subject to the exclusive jurisdiction of the courts located in Turkey.

7. Changes to Terms

We reserve the right to update or modify these Terms of Service at any time. Changes will be effective immediately upon posting to the website. Your continued use of the website or our products after any changes constitutes your acceptance of the revised Terms.