Legal Disclaimer

This disclaimer governs your use of MDR Academy and all content, tools, and services available on this platform. By accessing the platform, you acknowledge and accept the terms set out below. This disclaimer is an integral part of the Terms and Conditions applicable to this platform.

1. Informational Purpose Only

All content published on MDR Academy — including articles, guides, knowledge base entries, AI-assisted text, AI chat responses, form outputs, and any other materials — is provided for informational and educational purposes only.

Nothing on this platform constitutes legal advice, regulatory advice, medical device consulting, or professional consultancy of any kind. The content reflects the experience and understanding of MDR Academy's contributors in relation to EU MDR 2017/745 and the broader medical device regulatory landscape. It is not a formal interpretation of the law.

2. No Guarantee of Certification or Compliance Outcomes

MDR Academy does not guarantee, represent, or warrant that use of this platform — including use of the knowledge base, forms, AI chat, or MCP server — will result in a successful MDR certification, CE marking, IVDR compliance, or any other regulatory outcome.

The EU MDR 2017/745 process involves assessments by Notified Bodies and Competent Authorities whose decisions are independent and cannot be predicted or assured by any third party. Any content describing regulatory processes, requirements, or typical practices reflects experience and understanding — it is not a substitute for formal assessment by a qualified body.

3. No Professional or Advisory Relationship

Accessing or using MDR Academy — in any form, including browsing content, completing forms, using the AI chat, or connecting via the MCP server — does not establish any professional, advisory, or consulting relationship between you and MDR Academy or its operator, Bc. Karel Boháč.

You should not rely on the content of this platform as a substitute for advice from a qualified Regulatory Affairs professional, legal counsel, or other specialist appropriate to your situation.

4. Accuracy and Currency of Content

We make reasonable efforts to keep content accurate and up to date. However, the regulatory landscape — including EU MDR 2017/745, MDCG guidance documents, harmonised standards, common specifications, and Notified Body practices — is subject to ongoing change. MDR Academy does not guarantee that any content is complete, current, or reflective of the most recent regulatory developments.

Content on this platform was accurate to the best of our knowledge at the time of publication or last update. MDR Academy accepts no liability for decisions made on the basis of content that was accurate when published but has since been superseded by regulatory change.

Always verify critical information against current official sources, including the European Commission, the MDCG, EUDAMED, and your Notified Body.

5. AI-Assisted Content and EU AI Act

Parts of this platform involve content produced with AI assistance, and an AI chat interface that responds to user queries in real time.

AI-assisted knowledge base content is text produced with the help of AI tools, reviewed by a human before publication, and published to inform users on regulatory matters. In accordance with Article 50(3) of Regulation (EU) 2024/1689 (the EU AI Act), this content is disclosed as AI-assisted on the How AI Participates page, which constitutes MDR Academy's formal Article 50 transparency disclosure.

AI chat responses are generated in real time by a General Purpose AI model (Google Gemini API, provided by Google LLC). MDR Academy deploys this model as a deployer within the meaning of Article 3(4) of the EU AI Act and has implemented the transparency obligations applicable to limited-risk AI systems under Article 50(1). The AI chat notifies users at the start of each session that they are interacting with an AI system.

Liability for AI outputs: AI systems can produce errors, omissions, outdated answers, and plausible-sounding but incorrect statements. MDR Academy does not individually review AI chat responses before they are delivered. AI outputs — whether from the knowledge base content pipeline or from the live chat — carry the same informational-only status as all other content on this platform and must not be treated as authoritative regulatory guidance.

MDR Academy's obligations under the EU AI Act extend to the operation of this platform. Obligations that fall on the AI model provider — including GPAI provider obligations under Title VIII of the Act — are the responsibility of Google LLC, not MDR Academy.

6. Self-Assessment Forms

The self-assessment forms available on this platform generate personalised outputs based on the inputs you provide. These outputs — including device class indications and conformity assessment route summaries — are produced by rule-based logic applied to your stated inputs.

Form outputs are indicative only. They are based on the information you provide and the rules embedded in the form logic. They do not account for information you have not provided, nuances outside the scope of the form's parameters, or subsequent regulatory changes. MDR Academy accepts no liability for any decision, submission, or regulatory outcome based on a form output.

Form outputs are not a formal classification decision and do not constitute a determination by a Competent Authority or Notified Body.

7. MCP Server Content

Content retrieved via MDR Academy's MCP (Model Context Protocol) server is subject to the same informational-only status as all other content on this platform. MDR Academy accepts no liability for outputs, decisions, products, or regulatory submissions derived from content retrieved via the MCP server.

Responsibility for how MCP-retrieved content is used, processed, presented, or acted upon lies solely with the operator of the system that retrieves it. If you integrate MDR Academy content into an AI system, agentic workflow, or product, you are solely responsible for ensuring that integration complies with applicable law — including, where relevant, the EU AI Act — and does not misrepresent the nature or authority of the content.

8. External Links

This platform may contain links to external websites, including official regulatory sources, standards bodies, and third-party resources. MDR Academy is not responsible for the accuracy, completeness, content, or data protection practices of any third-party website. Links are provided for convenience and do not constitute an endorsement of the linked content or its source.

9. Data Protection

This disclaimer does not govern the processing of personal data. MDR Academy's obligations as data controller under Regulation (EU) 2016/679 (GDPR) — including your rights of access, rectification, erasure, and complaint — are set out separately in the Data Privacy Policy.

Nothing in this disclaimer limits or excludes any right you have as a data subject under GDPR, or any liability that may arise under Article 82 GDPR for unlawful processing of personal data.

10. Limitation of Liability

MDR Academy and its operator, Bc. Karel Boháč, accept no liability for any loss, damage, or consequence arising from:

• reliance on any content, tool, form output, AI response, or other material on this platform;
• any regulatory submission, certification process, technical file, or business decision made on the basis of information found here;
• errors, omissions, or inaccuracies in AI-generated or AI-assisted content;
• actions taken by any third-party AI system or workflow using content retrieved via the MCP server;
• the accuracy or currency of external sources linked from this platform;
• any interruption, suspension, or discontinuation of the platform or any of its tools.

This platform and all its content and tools are provided free of charge. In accordance with applicable Czech law (zákon č. 89/2012 Sb., Civil Code), the limitation of liability set out in this section applies to the fullest extent permitted for gratuitously provided services.

This limitation does not exclude liability for damage caused intentionally or by gross negligence, nor does it exclude liability for damage to life or health, as these cannot be contractually excluded under Czech law. It does not affect your rights as a consumer under applicable consumer protection law, or your rights as a data subject under GDPR.

11. Governing Law

This disclaimer is governed by the laws of the Czech Republic. Any dispute arising in connection with this disclaimer shall be subject to the jurisdiction of the competent courts of the Czech Republic.

For questions about this disclaimer, contact us at mrdacademy.eu@gmail.com.