Legal Notice & Disclaimer
This page summarises the legal terms under which Layon Med provides 3D computer-aided design and planning services to healthcare professionals and institutional partners. It does not replace a written contract or Data Processing Agreement.
This document is provided in several languages for convenience. In case of any discrepancy, the English version prevails.
1. Scope of service
Layon Med provides patient-specific 3D computer-aided design and digital surgical planning services to qualified healthcare professionals, hospitals, and dental laboratories. Layon Med does not diagnose patients, does not treat patients, and does not exercise clinical judgement. The treating clinician remains solely responsible for indication, surgical planning approval, intraoperative execution, and postoperative care.
Where Layon Med coordinates manufacturing through qualified manufacturing partners, the legal manufacturer of the finished medical device is the manufacturing partner, operating under its own quality management system (ISO 13485 or equivalent). Specific manufacturer, certificate, and notified-body identifiers are provided with each individual order to the prescribing clinician.
2. Custom-made devices — clinician responsibility
Devices designed by Layon Med are custom-made within the meaning of Regulation (EU) 2017/745 Annex XIII and Swiss MedDO Art. 9. They are produced on the basis of a written prescription issued by a duly qualified healthcare professional who, on the basis of his or her professional qualifications, designates the device's specific design characteristics and is responsible for its intended use in a specific individual patient.
By submitting a case, the prescribing clinician confirms that:
- they hold the appropriate professional licence and are authorised to prescribe and use custom-made devices in their jurisdiction;
- they have obtained informed patient consent for the design, manufacture and use of the device, including for any transfer of imaging data necessary for the design;
- they retain final clinical responsibility for indication, planning approval, intraoperative decisions, sterilisation per the supplied Instructions for Use, and follow-up care.
3. No warranty of clinical outcome
Layon Med makes no representation and gives no warranty, express or implied, regarding the clinical outcome of any surgical procedure in which a Layon Med design is used. Clinical outcomes depend on patient anatomy, comorbidities, the surgeon's intraoperative judgement, postoperative care, and factors outside Layon Med's control or knowledge.
Statements on this website describing typical workflow, turnaround, design accuracy, or capability are descriptive of the service, not guarantees of patient outcome.
4. Data handling — limitation of liability for data loss or corruption
Patient imaging data (DICOM / CT / CBCT / dental scans) and case files are processed only after a secure transfer channel has been arranged and, where applicable, a Data Processing Agreement is in place. Layon Med applies reasonable technical and organisational measures appropriate to the nature of the data (see the Privacy Notice).
To the maximum extent permitted by applicable mandatory law:
- Layon Med is not liable for loss, corruption, delay, interception, or unauthorised access to data submitted through insecure channels not designated by Layon Med (for example, ordinary email or third-party file-sharing platforms not part of the arranged secure channel);
- the prescribing clinician and the submitting institution remain responsible for maintaining their own back-up copies of imaging data and clinical records;
- Layon Med's liability for direct damages arising from data loss attributable to Layon Med is limited to the fees paid for the specific case in which the loss occurred; indirect, consequential, incidental, punitive, or reputational damages are excluded;
- these limitations do not apply where mandatory law (including Swiss CO Art. 100 and 101) prohibits exclusion or limitation in cases of wilful misconduct or gross negligence.
5. No advice to patients
This website is intended for healthcare professionals. Information presented is technical and operational; it does not constitute medical advice and must not be relied upon by patients or members of the public for decisions about their own care. Patients should consult their treating clinician.
6. Intellectual property and image rights
All text, illustrations, diagrams, CAD renders, and source code on this website are the property of Layon Med (or its licensors) unless explicitly attributed otherwise. Anatomical illustrations are derived from properly licensed or in-house generated assets; no patient-identifying imagery is published without documented consent.
Names of hospitals, universities, or clinicians are mentioned only where written consent from both the individual and the institution is on file. Unauthorised reproduction of website content is prohibited.
7. Third-party links and resources
Where this website links to third-party resources (for example, font providers or hosting platforms), Layon Med has no control over the content or practices of those third parties and accepts no responsibility for their availability, content, or processing of personal data. Use of third-party services is governed by their own terms and notices.
8. Force majeure
Layon Med is not liable for delay or failure to perform caused by events beyond its reasonable control, including but not limited to natural disasters, network failures, supply-chain disruption, regulatory action, pandemics, or acts of public authority.
9. Vigilance and serious-incident reporting
Suspected serious incidents involving a device designed or coordinated by Layon Med should be reported promptly to the treating institution's vigilance officer, to the legal manufacturer of the finished device, and — where required — to the competent authority (Swissmedic in Switzerland; the responsible national authority in EU/EEA member states). Layon Med cooperates fully with vigilance reporting obligations under MDR Art. 87 and Swiss MedDO.
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10. Governing law and jurisdiction
These terms are governed by the substantive law of Switzerland, excluding its conflict-of-laws rules and the United Nations Convention on Contracts for the International Sale of Goods (CISG). Exclusive place of jurisdiction for any dispute is the registered seat of Layon Med, subject to mandatory consumer-protection provisions where applicable.
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11. Changes to this notice
Layon Med may update this notice from time to time. The current version is the one published on this page; the date of last revision is recorded in the Impressum.
12. Contact
For legal enquiries, please use the contact channel published on the home page and reference "Legal — Disclaimer".
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