How we handle your case data.

Custom-made restorations and appliances — crowns, bridges, veneers, dentures, surgical guides, clear aligners — are custom-made medical devices under the Medical Devices Regulations 2002 (as amended) and are regulated by the MHRA.

The commissioning dentist or dental laboratory that provides the prescription and takes responsibility for the finished appliance remains the legal manufacturer of record, in line with GDC guidance. COSMODENTAL DESIGNS is a design partner: we produce the CAD design under your prescription, we do not place, fit, or dispense a device, and we do not hold the manufacturer obligation on your behalf.

To support your responsibility, every case we design ships back with:

• • The final design files in their native format plus a neutral STL / PLY export.
• • A traceable design log: designer initials, software version, revision history, and any prescription-related notes.
• • Full custody return — we retain nothing you have not asked us to keep.

COSMODENTAL DESIGNS does not currently hold ISO 13485 certification or an MHRA manufacturer registration. We do not describe ourselves as a medical-device manufacturer. If your workflow requires a supplier holding either, we'll tell you plainly that we're not the right partner.

• Storage: EU data centres only. Scan and case files are never mirrored to storage outside the EU without your written instruction.
• In transit: All uploads and downloads use TLS 1.2 or higher. Direct upload links are single-use and time-limited.
• At rest: AES-256 server-side encryption on stored objects.
• Access: Restricted to the assigned designer and case manager. Access is logged and audit-reviewed.

• Active retention: Case files are retained for 24 months after final delivery, so revisions, comparative planning, and regulatory queries are supported.
• Deletion on request: You can request early deletion of any individual case, or a full purge of all files associated with your account, at any time by emailing cosmolab@cosmodigitaldentalsolutions.com. We complete deletion within 30 days and confirm in writing.
• After 24 months: Files are automatically deleted unless you have asked for extended retention in writing.

We do not ask for or need patient identifiers to design a case. Please label uploads with a case reference (e.g.PRACTICE-2026-041) rather than the patient's name, and strip DICOM headers of patient identifiers before upload where practical.

Where DICOM identifiers are present, we treat them as controlled personal data under GDPR, restrict access to the assigned designer, and never reuse them for any other purpose.

COSMODENTAL DESIGNS processes data lawfully under GDPR: we act as a data processor on your behalf when we handle case files that contain patient personal data, and as a controller only for the account and billing data we hold about your practice or lab. Full detail, including lawful basis and your rights of access, rectification, and erasure, is on our Privacy Policy.