Ireland sits inside the EU regulatory framework and works in English — the easiest European market to onboard, and the one most often served badly by suppliers who treat it as an afterthought to the UK. It is not the same regime. We handle it as its own.
Since Brexit, Ireland has stayed inside the EU medical device framework while Great Britain went its own way. A supplier quoting you UKCA paperwork for an Irish practice has not read the file.
Clear aligners are Class IIa devices. Technical documentation, clinical evaluation and post-market surveillance maintained to MDR requirements. Declaration of conformity supplied with the first order.
Under MDR Article 11, a manufacturer outside the Union cannot place devices on the EU market without an appointed Authorised Representative — named on the label and reachable directly by the HPRA.
Single Registration Number for manufacturer and Authorised Representative, Basic UDI-DI per device family, UDI carriers applied per the MDR timetable.
Aligner treatment must be prescribed and supervised by a dentist registered with the Dental Council of Ireland. We manufacture to your prescription. We do not treat patients and we do not sell around the practitioner.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your supplier evaluation file.
Intraoral scans are special-category health data under Article 9 GDPR. Data Processing Agreement signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your practice remains the controller.
Full regulatory pack supplied on request before your first case.
Keep aligner cases in-house instead of referring them out. Submit an iTero or TRIOS scan, approve the 3D plan, receive the full course branded to your practice.
Add an aligner line to your existing prosthetics business without capital expenditure. You keep the practice relationship; we handle setup and production.
Full white label across packaging, portal and paperwork. Your logo on the box, ours nowhere — patients never see a supplier name.
| Stage | What happens | Time |
|---|---|---|
| 1. Scan received | STL or PLY uploaded to the doctor portal. Reviewed for clinical viability and file quality. | Same day |
| 2. 3D treatment setup | Digital setup produced — staging, attachments and IPR mapped movement by movement. | 24–48 hrs |
| 3. Your approval | Review in the portal, request modifications, approve. Unlimited revisions before production. | Your call |
| 4. Production and QC | Thermoforming on medical-grade multilayer sheet, trimming, polishing, batch QC, packaging. | 2–3 days |
| 5. Dispatch to Ireland | DDP express courier. Duties and customs settled at origin — nothing held at customs, no surprise invoice. | 5–7 days |
Invoicing in EUR. Import VAT position confirmed for your VAT number before the first shipment.
Upload a scan, review the 3D setup within 48 hours, and decide from there. No minimum order, no annual commitment.
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