Since the implementation of European Regulation MDR 2017/745, dentists who manufacture or modify custom-made medical devices (CMDs) are legally considered manufacturers.
This applies to more situations than you might think: whitening trays, surgical guides, retainers, study models…
👉 The question is simple: are you compliant with your obligations?
What does MDR 2017/745 require?
Each CMD produced or adapted in the practice must be supported by full traceability.
The practitioner must generate a certificate of conformity specifying:
- Type of device
- Date of manufacture
- Patient concerned
- Materials used
These certificates must be kept for 15 years.
Without them, practitioners are exposed to sanctions from DGCCRF and ANSM.
Common examples of CMDs produced in practice
- Whitening trays
- Retainers (wires + resin)
- Surgical guides
- Study models (plaster or resin)
- Fluoride or bruxism trays
👉 Many dentists already produce these devices without realizing it—and are therefore automatically considered manufacturers.
Risks of non-compliance
- DGCCRF or ANSM inspection → formal notice, fines, or even temporary closure of the practice
- Patient incident → civil and criminal liability
- Practice reputation → loss of credibility with patients and peers
Limits of traditional methods
📒 Paper → unreliable, often incomplete
📊 Excel spreadsheets → unsecured and time-consuming
🗒️ Post-it notes → no legal value
👉 These methods create a false sense of security but do not protect your practice.
How DentoTrack simplifies CMD certification
DentoTrack is specifically designed for dentists. It allows you to:
- Automatically certify each CMD produced in your practice
- Generate and store certificates in one click
- Link each certificate to the patient record
- Ensure legal compliance in case of inspection
- Provide unlimited access for the entire team, across all workstations
👉 One subscription, full protection for your entire practice.
Custom-made medical devices are part of daily life in many dental practices. But since MDR 2017/745, ignoring traceability means exposing yourself to significant legal and financial risks.
With DentoTrack, compliance becomes simple, fast, and automated.
👉 Protect your patients and your practice today: request a DentoTrack demo.
