Medical Device Compliance
Last updated: 21 July 2026
Custom-milled dental restorations manufactured by MillMyArch are custom-made medical devices. This page summarises our approach to regulatory compliance, manufacturer identification and traceability.
1. Custom-made devices
The full-arch zirconia and PMMA restorations we manufacture are produced to the individual prescription and digital design supplied by a named dental professional for a specific patient. Under the EU Medical Device Regulation (EU) 2017/745 (MDR), these are “custom-made devices”. Equivalent principles apply for UK-market devices under the UK Medical Devices Regulations (overseen by the MHRA).
2. Statement / Declaration for custom-made devices
For each order, a statement for custom-made devices (in line with MDR Annex XIII) can be provided on request. It confirms that the device is intended for the sole use of the named patient, identifies the prescribing professional, and states that the device meets the relevant general safety and performance requirements, noting any characteristics that derive from the prescription.
3. Manufacturer identification
Manufacturer: MillMyArch, United Kingdom.
Quality & manufacturing enquiries: [email protected]. General enquiries: [email protected].
4. Material traceability & lot information
We maintain traceability for each case. Records link the job number to the material used (including type/shade) and the corresponding lot/batch information, together with the submitted design files. This supports post-market traceability and any required record-keeping for the retention period defined in applicable medical-device regulations.
5. Quality standards
Our manufacturing operates to recognised quality standards, including ISO 13485, MHRA, FDA. Vigilance and quality concerns can be reported to [email protected].