Dental products, aligners and lab materials

• Regulation (EU) 2017/745 — Medical Devices, including custom-made devices
• Regulation (EC) No 1223/2009 for whitening products
• Regulation (EU) 2017/746 for diagnostic products

Who has to appoint one

Manufacturers outside the Union placing dental devices on the EU market, including direct-to-consumer aligner companies. Aligners are custom-made devices with a specific regime, and the treatment plan and remote supervision raise additional questions in several member states.

Thresholds and exemptions

None. Custom-made devices are not exempt: they require a statement under Annex XIII, technical documentation and registration of the manufacturer.

What must appear on the label

CE marking where applicable, manufacturer and EC REP details, UDI for series-produced devices, the custom-made statement for bespoke ones, lot identification and the instructions for use.

Marketplace fields

Direct-to-consumer aligner services have faced regulatory action in several member states over remote treatment without adequate clinical supervision, independently of the device conformity.

Documentation you must hold

MDR technical documentation, clinical evaluation, risk management, post-market surveillance, EUDAMED registration and the Article 11 mandate. For custom-made devices, the Annex XIII statement and the documentation identifying the manufacturing site.

Standards and testing

Biocompatibility under ISO 10993 for materials in prolonged mucosal contact, mechanical testing for the material and the device, and for whitening products the cosmetic peroxide limits.

Language requirements

Instructions and patient information in the language of each member state of supply.

When it applies

Before placing on the market or supplying the custom device.

How long records are kept

Ten years under the MDR.

What happens if you do not comply

Withdrawal, prohibition and shared liability of the authorised representative. Several member states have additionally restricted direct-to-consumer orthodontics on professional practice grounds.

Who enforces it

Medical device competent authorities, national dental regulators and cosmetics authorities for whitening products.

Where the boundary lies

Professional whitening gels above 0.1% peroxide may only be supplied to dental practitioners for first use, and above 6% may not be placed on the market at all. Aligners are devices even when the customer never meets a dentist, and the absence of clinical supervision is a separate regulatory issue.

Questions we are asked

Are clear aligners custom-made devices?

Generally yes, produced to a prescription for an individual patient, which brings the Annex XIII regime rather than the standard CE marking route.

Can we sell professional whitening gel online?

Products above 0.1% peroxide may only be sold to dental practitioners for the first use cycle, which excludes ordinary consumer sale.