Dental prosthetics as medical device — CE documentation and traceability
Every single crown, bridge and denture is a specially manufactured medical device with documentation requirements
A crown a bridge a prosthesis or a splint is not just a craft product — it's legally a medical device. The manufacture of dental work is regulated by the EU Medical Device Regulation (EU) 2017/745 which came into full effect in 2021. The dental technician and lab are in this context the manufacturer of what the regulation calls custom-made devices.
§What is specially manufactured equipment?
Custom-made device is characterized by being manufactured individually according to written instructions - a prescription - from a person with the necessary professional qualifications, typically a dentist, and that it is intended for use for one specific, named patient. For this reason crowns, bridges, dentures, and splints are covered: each piece is unique and made for one mouth. Unlike mass-produced devices, custom-made devices generally should not be CE-marked, but it is far from exempt from regulations - the requirements shift instead to documentation and traceability.
§What must be documented?
For each specially manufactured equipment the manufacturer must prepare a statement that among other things identifies the manufacturer describes the equipment unambiguously and confirms that the equipment meets the general safety and performance requirements in annex I of the regulation — or states which requirements are not fully met and why. The statement must be kept so it can be shown during inspection and it is connected to continuous traceability: which materials and batches were used for this specific work when was it manufactured and by whom.
- 01Declaration for specially manufactured equipment with manufacturer information and equipment identification.
- 02Documentation of which materials and batch/LOT numbers have been used.
- 03Connection between order patient and finished equipment so an error can be traced back.
- 04Storage of documentation in the period that the regulations prescribe.
- 05Routines for responding if a material or batch later proves to be problematic.
| Dokument/oplysning | Content | Why it is important |
|---|---|---|
| Declaration for specially manufactured equipment. | Manufacturer, equipment, confirmation of conformity | Legal requirements versus good practice |
| Material and batch documentation | What material and what batch was used | Make it possible to trace an error to specific patients |
| Sag/ordre-dokumentation | Connection between prescribing dentist patient and product | Ensures that work can be traced all the way back |
§Why traceability matters
Traceability sounds abstract until it becomes necessary. If a specific alloy batch later proves to release unexpected substances, or if an error is discovered in a specific ceramic type, it is the traceability documentation that makes it possible to quickly find out which patients received work done with that exact material – and react before it becomes a bigger problem. Good documentation is therefore not bureaucracy for bureaucracy's sake, but part of patient safety.
For the newly trained dental technician it is worth getting used to from day one that documentation belongs just as much to the trade as grinding colouring and polishing. A perfectly fitted work without correct documentation is still work that does not meet the rules.
“What you don't write down you can't prove afterwards — either to the authority or to yourself.”