Traceability scheme: documentation of dental medical devices
Practical template for documenting material, batch and responsibility for each work
§Purpose
The form is used to compile the documentation that the Medical Device Regulation (MDR) requires for specially made dental technical work. It is completed for each new case and saved with the rest of the case documentation so the information can be retrieved if questions later arise about a specific material patient or period.
| Field | Filled in with. |
|---|---|
| Sags-/ordrenummer | Laboratory's internal serial number |
| Prescribed diet plan and any restrictions. | Name and clinic address |
| Patient ID | Internal, anonymized code – not full personal information in the form itself |
| Product type | Crown / bridge / prosthesis / splint / other |
| Material(s) used | E.g. zirconia, lithium disilicate, cobalt-chrome, acrylic |
| Batch-/LOT-nummer | From material's packaging or accompanying document |
| Manufacturing date | Date of completion at the laboratory |
| Responsible dental technician | Name/initials of the person who performed the work |
| Declaration attached (yes/no). | Whether the declaration for custom-made equipment has been prepared |
| Delivery date | Date for delivery to clinic/patient |
- 01The form is completed by the dental technician who finishes the work — not by someone else at a later time.
- 02Batch/LOT numbers are recorded as soon as the material is put into use, not from memory afterwards.
- 03Forms for the same material batch should be retrievable collectively if a batch is later withdrawn.
- 04Store the documentation in the period that the laboratory's quality procedures and regulations prescribe.
- 05In doubt about whether a job requires special documentation ask the quality officer rather than guessing.
A consistently filled traceability sheet costs a few minutes per case but can save the laboratory hours of uncertain searching if it one day needs to answer which patients received work with a particular material.