Terms of Service
Last updated: 29 July 2026
1. Operator and scope
Medical Device Watchdog is a product operated by Genlabs Group SL, Tax ID B21641469, Gran Via 1, 48001 Bilbao, Biscay, Spain. These terms apply to medicaldevicewatchdog.com, app.medicaldevicewatchdog.com, and the submission, account, evidence, and status-tracking features provided through them.
Contact us at legal@medicaldevicewatchdog.com. Nothing in these terms limits mandatory rights that apply to you as a consumer or under data-protection, whistleblower, employment, medical-device, or other applicable law.
2. What the service currently provides
A signed-in user can save a draft, identify a medical device, record observations and regulatory questions, upload evidence, submit the concern, choose whether contact details may be included in an external report, and view the status stored in the application.
MD Watchdog is not a competent authority, notified body, conformity-assessment body, medical provider, or law firm. The service does not determine compliance and does not provide medical, legal, employment, whistleblower, or regulatory advice.
Submission does not guarantee that a reviewer will be assigned, that a report will be filed, that an authority will accept or investigate it, that a manufacturer will respond, or that any corrective or enforcement action will occur. Expedited review is not currently available for purchase.
3. Accounts and the identity preference
Sign-in is required to use the submission application. We therefore know the email address associated with your account and store the report under that account. You are responsible for securing your sign-in method and notifying us of suspected unauthorised access.
If you select the identity-withholding option, you ask MD Watchdog not to include your contact details in an external report. This does not make you anonymous to MD Watchdog, remove identifying details from evidence, guarantee that the facts cannot reveal the source, or prevent disclosure when law, regulation, a court order, or a valid safety and security obligation requires it.
Read the privacy policy for information about personal-data processing. Review every attachment for names, account identifiers, notifications, location data, and document metadata before uploading.
4. Your submission
You must provide information that you reasonably believe is accurate and clearly distinguish direct observations from assumptions or allegations. You must not knowingly submit fabricated, malicious, unlawfully obtained, or materially misleading content.
You must have the right to upload and permit us to process the evidence. Do not submit unnecessary patient identifiers, special-category data, trade secrets, privileged material, or confidential employer records. If disclosure rights or retaliation risk are uncertain, obtain advice from a qualified lawyer, union, or authorised whistleblower-support body before submitting.
You retain ownership of your content. You grant Genlabs Group SL a limited, non-exclusive licence to store, secure, reproduce, format, and use it only as reasonably necessary to operate the service, investigate misuse, respond to your request, and, where you have authorised it, prepare or transmit an external report.
5. Public evidence reviews
A private submission is not automatically a public article. Before publishing user-supplied evidence that is not already public, we will need a lawful basis and any permission required for the intended use. We may redact personal or confidential details.
Public evidence reviews express documented observations and regulatory questions. They are not authority findings. A page will state that an authority filing is verified only when a public receipt or authority record supports that statement.
6. Automated assistance
The application may use automated systems to suggest regulatory references or generate a working draft. Automated output can be incomplete or wrong. It must not be treated as professional advice or an authority decision.
No AI-generated draft should be sent externally without authorised human verification of every material fact, source, quotation, device identifier, legal citation, jurisdiction, and requested action. Current reviewer availability and qualifications are not promised by these terms.
7. Fees and paid services
The current submission and tracking features are free. Expedited review and filing are paused and should not be offered at checkout while this service status is in force.
If a paid service is introduced later, the checkout and applicable terms must state the total price including taxes where required, the exact deliverable, the provider, service-start request, expected timing, cancellation and withdrawal rights, refund and remedy rules, and any material limitation before payment.
If you previously paid for an expedited service, contact legal@medicaldevicewatchdog.com with the payment reference. The terms and mandatory rights applicable at the time of purchase continue to govern that payment.
8. Consumer withdrawal rights
Where EU or Spanish consumer law applies to a future distance contract for services, a consumer generally has fourteen days from contract formation to withdraw. If the consumer expressly asks us to begin during that period and later withdraws before completion, the consumer may owe a proportionate amount for service properly supplied up to withdrawal where the law permits.
A consumer loses the service withdrawal right only after full performance when the required prior express consent and acknowledgement have been obtained. We will not rely on a waiver that the checkout did not obtain and confirm as required by law.
9. Acceptable use
You must not use the service to:
- harass, threaten, defame, or impersonate another person;
- submit a concern for an unlawful anti-competitive, extortionate, retaliatory, or deceptive purpose;
- upload malware or attempt to bypass access controls;
- access another user's account or submission;
- interfere with availability, integrity, or security; or
- scrape private or authenticated areas without written permission.
10. Moderation and account action
We may reject, quarantine, restrict, or remove content when reasonably necessary to address illegality, security risk, privacy harm, intellectual-property claims, abuse, false reporting, or a material breach of these terms. We may suspend an account for the same reasons.
Where appropriate and lawful, we will explain the action and allow the user to contact us. Immediate action may be necessary for security, legal compliance, or risk to another person.
11. Service availability and third parties
We aim to keep the service available but do not promise uninterrupted operation. Authentication, hosting, storage, email, payment, AI, and authority websites may depend on third parties. Their availability and decisions are outside our control.
Links to laws, authorities, databases, and other sites are provided for reference. Check the current official source before acting.
12. Intellectual property
The service software, design, branding, and original editorial material belong to Genlabs Group SL or its licensors. These terms do not transfer those rights. You may link to public pages and use material where applicable law or a stated licence permits.
13. Safety and professional advice
Do not delay emergency care, clinical advice, a mandatory report, or a direct authority report because of MD Watchdog. Contact local emergency services for an emergency and a qualified healthcare professional for a device-related health concern.
14. Liability
To the extent permitted by applicable law, Genlabs Group SL is not responsible for an authority's, manufacturer's, platform's, or other third party's independent decision, or for loss caused by inaccurate user material or use of the service contrary to these terms.
Nothing in these terms excludes or limits liability that cannot lawfully be excluded or limited, including mandatory consumer remedies and liability for fraud, wilful misconduct, or death or personal injury where exclusion is prohibited. No arbitrary monetary cap overrides those rights.
15. Governing law and disputes
Spanish law governs these terms, without depriving a consumer of mandatory protections provided by the law of the consumer's habitual residence. Consumers may bring proceedings in any court available to them under mandatory law. These terms do not impose exclusive jurisdiction in Bilbao on a consumer.
Please contact us first so we can try to resolve a service issue. This request does not suspend or replace any statutory complaint period, authority route, or right to bring proceedings.
16. Changes
We may update these terms to reflect a changed service, law, or risk. Material changes affecting registered users will be communicated through the service or by email where appropriate. Changes do not retroactively remove rights or alter an already purchased service without a lawful basis.
17. General provisions
If a provision is unenforceable, the remaining provisions continue to apply. A failure to enforce a provision is not a waiver. The English version is the current service version.