Europe / France
France · EU MDR · ANSM

Clear aligner manufacturing for French practices

Orthodontic aligner cases without the capital outlay. We produce the 3D treatment setups and manufacture the aligners; your cabinet or laboratoire keeps the patient relationship, the prescription and the margin. CE-marked under MDR, French-language documentation, DDP delivery in 6–8 days.

6–8 daysDDP delivery to France
48 hrs3D setup turnaround
No minimumStart with one case
Dental professionals partnering with Clear Moves Aligners in France
CE markingEU MDR 2017/745ISO 13485 certifiedFDA 510k cleared K241137MHRA registered
Regulatory

France is strict on language and on the prescriber

Two things trip up aligner suppliers entering the French market: documentation that is not in French, and any suggestion that a patient can be treated without a chirurgien-dentiste. We do neither.

01

CE under EU MDR 2017/745

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.

02

EU Authorised Representative

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 ANSM.

03

French-language documentation

Instructions for use, wear schedules and patient care material supplied in French. Information accompanying a device placed on the French market must be in French — an English-only IFU is a compliance gap.

04

Prescriber-led, always

Aligner treatment in France is prescribed and supervised by a chirurgien-dentiste or an orthodontiste. We manufacture to your prescription. We do not treat patients and we do not sell around the practitioner.

05

ISO 13485 quality system

Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your supplier evaluation file.

06

RGPD and scan data

Empreintes numériques are données de santé under Article 9 GDPR. Data Processing Agreement signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your cabinet remains the controller.

Full regulatory pack supplied on request before your first case.

Who we work with

Built for three kinds of French partner

Cabinets dentaires

Keep aligner cases in-house rather than referring them out. Submit a TRIOS or Primescan file, approve the 3D plan, receive the full course branded to your practice.

Laboratoires de prothèse

Add an aligner line to your existing prosthetics business without capital expenditure. You keep the practice relationship; we handle the setup and the manufacturing.

French aligner brands

Full white label across packaging, portal and paperwork. Your logo on the box, ours nowhere — your patients never see a supplier name.

Turnaround

Scan in Lyon, aligners on the bench in about a week

StageWhat happensTime
1. Scan receivedSTL or PLY uploaded to the doctor portal. Reviewed for clinical viability and file quality.Same day
2. 3D treatment setupDigital setup produced — staging, attachments and IPR mapped movement by movement.24–48 hrs
3. Your approvalReview in the portal, request modifications, approve. Unlimited revisions before production.Your call
4. Production and QCThermoforming on medical-grade multilayer sheet, trimming, polishing, batch QC, packaging.2–3 days
5. Dispatch to FranceDDP express courier. Duties and customs settled at origin — nothing held at the douane, no surprise invoice.6–8 days

Invoicing in EUR. Import VAT position confirmed for your numéro de TVA before the first shipment.

FAQ

What French partners ask

Is the documentation in French?
Yes. Instructions for use, wear schedules and patient care material are supplied in French. Regulatory certificates are supplied in their issued language, with a French summary on request.
Who is the legal manufacturer if we sell under our own brand?
Clear Moves Aligners is the legal manufacturer and holds the technical file. If you place devices on the market under your own name, MDR Article 16 obligations may transfer to you. We will walk your regulatory adviser through which arrangement applies before your first order.
Do you sell aligners directly to French patients?
No. Every case is prescribed and supervised by a chirurgien-dentiste or orthodontiste. We manufacture to the practitioner s prescription and never bypass them.
Which scanners do you accept?
3Shape TRIOS, Dentsply Primescan, CEREC Omnicam, iTero Element and 5D, Medit i500 and i700, Carestream CS 3600. Any STL, PLY or OBJ export. PVS impressions also accepted.
Is there a minimum order?
No. Send one case, evaluate the setup, the material and the packaging, and decide from there.

Send one French case. Judge us on it.

Upload a scan, review the 3D setup within 48 hours, and decide from there. No minimum order, no annual commitment.

Start your first French case

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