Terms of Service

1. Acceptance of Terms

By accessing or using the RegAffairs Hub website (regaffairshub.com), including any of its tools, blog content, or services (collectively, the “Service”), you agree to be bound by these Terms of Service (“Terms”). If you do not agree to all of these Terms, you must not access or use the Service.

These Terms constitute a legally binding agreement between you (“User,” “you,” or “your”) and Urviproject (“RegAffairs Hub,” “we,” “us,” or “our”), the operator of regaffairshub.com. By using the Service, you represent that you are at least 18 years of age and have the legal capacity to enter into these Terms.

2. Description of Services

RegAffairs Hub provides free, web-based regulatory affairs tools and educational blog content designed for biotech, medical device, and pharmaceutical professionals. Our current services include:

• MDR Classification Wizard: A step-by-step tool that guides users through EU MDR Annex VIII classification rules to help determine the risk class of a medical device.
• Submission & Document Tracker: A tool for tracking regulatory submissions from draft through approval and organizing technical documentation, with portfolio overview and audit trail capabilities.
• Blog: Expert articles covering EU MDR, IVDR, FDA submissions, eCTD structure, clinical evaluations, QMS, and broader regulatory strategy.

We reserve the right to modify, suspend, or discontinue any part of the Service at any time, with or without notice. We shall not be liable to you or any third party for any modification, suspension, or discontinuation of the Service.

3. Tool Disclaimer — Classification Wizard

The MDR Classification Wizard provides indicative results only. The classification outputs generated by this tool do NOT constitute definitive regulatory classifications.

The Classification Wizard is designed as an educational aid to help users understand EU MDR Annex VIII classification rules. However, the regulatory classification of a medical device is a complex determination that depends on numerous factors, including the specific intended purpose, device characteristics, clinical context, and evolving regulatory interpretations.

Users must independently verify all classification results with qualified regulatory affairs professionals, legal counsel, and/or their Notified Body before relying on them for any regulatory, commercial, or compliance decision.

RegAffairs Hub is NOT a Notified Body, competent authority, or regulatory authority. We do not issue certificates, approve devices, or make binding regulatory determinations of any kind. The use of our Classification Wizard does not create a professional-client relationship, regulatory consultancy engagement, or advisory relationship between RegAffairs Hub and the User.

Classification rules may be subject to different interpretations by different Notified Bodies and competent authorities. Regulatory guidance and case law evolve over time. The tool may not reflect the most recent regulatory updates at any given moment.

4. Blog Content Disclaimer

All blog articles, guides, and editorial content published on RegAffairs Hub are provided for educational and informational purposes only. Blog content does not constitute regulatory advice, legal advice, professional consultancy, or any form of binding guidance.

While we strive to ensure accuracy and timeliness, the regulatory landscape changes frequently. Articles may reference regulations, guidance documents, or deadlines that have since been updated or superseded. Users should always verify information against the latest official sources (e.g., European Commission, FDA, MDCG guidance documents) before making compliance decisions.

No professional-client, advisory, or consultancy relationship is created by reading or relying on our blog content.

5. User Accounts

Certain features of the Service, such as the Submission & Document Tracker, may require you to create a user account. When creating an account, you agree to:

• Provide accurate, current, and complete information during registration and keep your account information up to date.
• Maintain the confidentiality and security of your login credentials (username and password). You are solely responsible for all activity that occurs under your account.
• Notify us immediately at hello@regaffairshub.com if you become aware of any unauthorized use of your account or any other breach of security.
• Not share your account credentials with third parties or allow others to access the Service through your account.

We reserve the right to suspend or terminate your account at our discretion if we reasonably believe that you have violated these Terms or that your account has been compromised.

6. Acceptable Use

You agree to use the Service only for lawful purposes and in accordance with these Terms. Specifically, you agree not to:

• Use the Service in any way that violates any applicable local, national, or international law or regulation.
• Attempt to gain unauthorized access to any part of the Service, other user accounts, or any systems or networks connected to the Service.
• Use automated scripts, bots, scrapers, or similar technologies to access, collect, or extract data from the Service without our prior written consent.
• Commercially redistribute, resell, sublicense, or republish any content, tool outputs, or materials obtained from the Service.
• Interfere with or disrupt the integrity or performance of the Service or the servers and networks that host it.
• Upload or transmit viruses, malware, or any other malicious code through the Service.
• Impersonate any person or entity, or misrepresent your affiliation with any person or entity.
• Use the Service to send unsolicited commercial communications (spam) or for any fraudulent purpose.

7. Intellectual Property

All content on the Service, including but not limited to text, articles, blog posts, tool interfaces, tool logic, graphics, logos, icons, images, software, and the overall design and arrangement of the website (collectively, “Content”), is the property of Urviproject or its licensors and is protected by copyright, trademark, and other intellectual property laws.

You may access, view, and print Content from the Service for your personal, non-commercial use only. You may not copy, reproduce, distribute, modify, create derivative works from, publicly display, or commercially exploit any Content without our prior written permission.

The RegAffairs Hub name, logo, and all related trademarks, service marks, and trade names are the property of Urviproject. Nothing in these Terms grants you any right to use our trademarks without our prior written consent.

8. Limitation of Liability

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, REGAFFAIRS HUB, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND AFFILIATES SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, REVENUE, DATA, BUSINESS OPPORTUNITIES, OR GOODWILL, ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF THE SERVICE, REGARDLESS OF THE THEORY OF LIABILITY.

Without limiting the foregoing, RegAffairs Hub accepts NO LIABILITY whatsoever for any decisions, actions, regulatory submissions, compliance strategies, or commercial outcomes made or pursued based on:

• Results or outputs generated by the MDR Classification Wizard, including any device classification, risk class determination, or rule interpretation provided by the tool.
• Information, guidance, or opinions expressed in blog articles or any other editorial content published on the Service.
• Data entered into or stored by the Submission & Document Tracker, including any loss of data, inaccurate tracking, or missed deadlines.

The Service is provided on an “AS IS” and “AS AVAILABLE” basis without warranties of any kind, whether express or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, accuracy, completeness, or non-infringement.

You acknowledge and agree that your use of the Service, including reliance on any tool output or content, is entirely at your own risk. You are solely responsible for verifying any information obtained through the Service with qualified regulatory professionals before making compliance or business decisions.

9. Indemnification

You agree to indemnify, defend, and hold harmless Urviproject, its officers, directors, employees, agents, and affiliates from and against any and all claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys’ fees) arising out of or in any way connected with:

• Your access to or use of the Service.
• Your violation of these Terms.
• Your violation of any third-party rights, including intellectual property or privacy rights.
• Any regulatory decisions, submissions, or compliance actions taken based on information or tool outputs obtained from the Service.
• Any content or data you submit, upload, or transmit through the Service.

10. Modifications to Terms

We reserve the right to modify or update these Terms at any time at our sole discretion. When we make changes, we will update the “Last updated” date at the top of this page. Material changes may also be communicated through a notice on the website or via email to registered users.

Your continued use of the Service after any changes to these Terms constitutes your acceptance of the revised Terms. If you do not agree to the updated Terms, you must stop using the Service immediately.

We encourage you to review these Terms periodically to stay informed of any updates.

11. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the Principality of Andorra, without regard to its conflict of law provisions.

Any disputes arising out of or relating to these Terms or your use of the Service shall be subject to the exclusive jurisdiction of the courts of Andorra. You consent to the personal jurisdiction of such courts and waive any objection to the exercise of jurisdiction over you by such courts.

12. Severability

If any provision of these Terms is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction, such provision shall be modified to the minimum extent necessary to make it valid and enforceable, or if modification is not possible, shall be severed from these Terms. The invalidity or unenforceability of any provision shall not affect the validity or enforceability of the remaining provisions, which shall continue in full force and effect.

13. Contact Information

If you have any questions, concerns, or requests regarding these Terms of Service, please contact us at:

Urviproject
Plaça Bartomeu Rebés Duràn, 5, AD500 Andorra la Vella, Andorra
Email: hello@regaffairshub.com

You may also reach us through our contact page.