Practical checklist for dental and orthodontic practices
DGCCRF inspections (French Directorate General for Competition, Consumer Affairs and Fraud Control) are increasing in the dental sector. Their goal? To ensure that practitioners comply with their obligations regarding the manufacturing and traceability of custom-made medical devices (CMDs).
👉 You become a manufacturer as soon as you produce a device within your practice (aligners, retention wires, trays, guides, models, etc.).
👉 Without full traceability, you risk severe penalties (up to €375,000 in fines and 2 years of imprisonment under the Public Health Code).
So, are you ready for an inspection? Here is your practical checklist.
✅ Compliance checklist for your practice:
1. CMD traceability file
- Maintain a manufacturing record for each device (date, patient, practitioner, type of device, materials used).
- Keep batch numbers and references of materials (resins, wires, trays, etc.).
- Be able to provide proof quickly if requested by an inspector.
2. Certificates of conformity
- Provide each patient with a CE certificate of conformity for their device.
- Archive these certificates for 10 years (legal requirement).
3. Internal organization
- Use a clear and centralized system (avoid post-it notes, notebooks, or scattered Excel files).
- Delegate traceability management to assistants using an appropriate tool.
4. Regulatory compliance
- Ensure compliance with MDR 2017/745.
- Anticipate inspections with software capable of exporting full traceability in one click.
5. Patient communication
- Be able to clearly explain patients’ rights and guarantees.
- Provide their certificate immediately upon request.
⚠️ Most common issues identified by DGCCRF
- Missing or incomplete certificates
- Untracked materials (no batch numbers)
- Scattered, incomplete, or inaccessible records
- Inability to provide documents during inspection
🚀 How to be ready now?
The simplest way to stay compliant with peace of mind:
- Centralize all traceability in dedicated software
- Automatically generate certificates of conformity
- Ensure compliance with MDR requirements
👉 With OrthoTrack (orthodontics) and DentoTrack (dental), with a single subscription for the entire practice, you are covered:
- Unlimited practitioners
- Unlimited patients
- Unlimited workstations
In case of inspection, you can generate certificates and full traceability in just a few clicks.
🎯 Conclusion
A DGCCRF inspection is not a threat… if you are prepared.
With proper organization and the right tools, this obligation becomes a safeguard for your practice and your patients.
🔒 Start today.
One key principle: traceability.
