Since May 2021, European Regulation MDR 2017/745 has been in force. For orthodontists, this brings a new responsibility: every custom-made medical device (CMD) produced or delivered in the practice must be traceable, certified, and archived.
In 2025, ignoring traceability means risking penalties, fines, and loss of professional credibility.
👉 Good news: with software like OrthoTrack, compliance becomes simple, fast, and beneficial for the entire team.
Why CMD traceability is mandatory
An orthodontist who manufactures an aligner, retainer, surgical guide, or study model is legally considered a manufacturer.
As a manufacturer, they must:
- Identify each device (batch, date, machine used)
- Link it to the patient’s history
- Generate and retain a certificate of conformity
The goal: protect patients and ensure full traceability in case of issues.
Risks of non-compliance
In France, inspections are carried out by ANSM and DGCCRF.
- Without traceability → risk of formal notice, fines, or temporary closure
- In case of patient incidents → civil and criminal liability
- During inspections → lack of digital proof leaves the practice fully exposed
Common mistakes in practices
📒 Paper notebooks → quickly incomplete, illegible, unusable
📊 Excel → time-consuming, error-prone, not compliant with HDS standards
🗒️ Post-it notes → no legal value
👉 These methods do not ensure compliance or security and lead to daily time loss.
How OrthoTrack ensures traceability and organization
OrthoTrack was designed by orthodontists to meet real clinical needs:
- Automated traceability of CMDs: aligners, surgical guides, retention wires, indirect bonding trays, resin or plaster models
- Certificates generated in one click and archived in a secure healthcare cloud (HDS)
- Optimized internal organization with integrated planning (no more Excel or notebooks)
- Universal compatibility with 3D printers, thermoforming machines, and intraoral scanners
- Unlimited users: the entire practice is covered with a single subscription
In 2025, traceability of custom-made medical devices is no longer optional—it is a legal obligation and a guarantee of patient safety.
With OrthoTrack, you turn a regulatory constraint into an organizational and economic advantage:
- Guaranteed MDR compliance
- Protected practice
- More efficient team
👉 Request a free demo today and discover how OrthoTrack can secure and simplify your daily workflow.
