Disclaimer

Not a Substitute for Professional Advice

The classification results generated by DeviceCompass are based on the answers you provide to structured decision trees. These results are intended to:

• →Provide a preliminary indication of the likely regulatory classification
• →Help you understand the decision logic behind classification rules
• →Generate documentation of the classification reasoning for your records
• →Serve as a starting point for discussions with regulatory consultants and Notified Bodies

They are not a substitute for formal regulatory assessment by a qualified regulatory affairs professional, legal counsel, Notified Body, or Competent Authority.

Accuracy & Completeness

While we make every effort to ensure our decision trees accurately reflect the current regulatory requirements, we cannot guarantee that:

• →The classification logic is complete or accounts for every possible device scenario
• →Recent amendments, corrigenda, or guidance updates have been incorporated
• →The AI interpretation of device descriptions will always map to the correct classification path
• →The risk scoring model precisely matches the methodology used by any specific regulatory body

Regulatory frameworks are complex and subject to interpretation. Borderline cases, novel devices, and combination products may require expert analysis beyond what any decision-support tool can provide.

Regulatory Frameworks Covered

DeviceCompass currently covers the following frameworks:

• →EU MDR 2017/745 — Based on Annex VIII classification rules (Rules 1–22)
• →EU IVDR 2017/746 — Based on Annex VIII classification rules (Rules 1–7)
• →FDA Classification — Based on 21 USC §360c and CDRH product classification
• →ISO 14971:2019 — Risk management scoring based on severity, probability, and detectability

These implementations represent our interpretation of the published regulations and standards. They may not cover every edge case or recent amendment. Always refer to the official regulation text for definitive guidance.

AI-Assisted Interpretation

Where DeviceCompass uses AI models to interpret free-text device descriptions, the interpretation is probabilistic and may contain errors. AI-suggested classification paths should always be reviewed and validated by a qualified human before being relied upon. The AI does not have access to your full technical file, clinical data, or intended use context beyond what you provide in the text field.

Your Responsibility

As the user of DeviceCompass, you are responsible for:

• →Providing accurate and complete information about your device
• →Verifying classification outputs against the applicable regulation text
• →Engaging qualified regulatory professionals for formal classification decisions
• →Maintaining compliance with all applicable laws and regulations in your target markets
• →Understanding that DeviceCompass classifications do not guarantee regulatory acceptance

Limitation of Liability

DeviceCompass, its creators, employees, and affiliates shall not be held liable for any damages, losses, regulatory penalties, market access delays, or other consequences arising from reliance on classification outputs produced by the Service. This includes but is not limited to incorrect classifications, missed regulatory requirements, or delays in obtaining market authorisation.

Contact

If you have questions about this disclaimer or the accuracy of our classification logic, contact us at support@devicecompass.io.