💡 Everything you need to know, without unnecessary jargon
Since May 2021, the European Regulation MDR 2017/745 has been fully in force.
Behind this technical acronym lies a simple reality: as soon as you manufacture or have manufactured a custom-made medical device (CMD) — aligners, trays, retention wires, surgical guides, etc. — you must comply with specific rules regarding traceability and compliance.
1. Why was this regulation introduced?
🎯 Protect patients
Ensure that each device is manufactured according to a clear, documented, and secure protocol.
⚖️ Make practitioners accountable
As soon as you manufacture or have a CMD manufactured, you are legally considered a manufacturer under MDR.
🌍 Harmonize practices across Europe
Authorities (DGCCRF, ANSM, etc.) are increasing inspections in practices to ensure compliance with regulations.
2. What it changes in your daily practice
✅ A certificate of conformity must be issued for each device manufactured or prescribed.
✅ Full traceability must be ensured for 10 years: origin, manufacturer, patient, materials, etc.
✅ In the event of an inspection, this information must be immediately available.
⚠️ Without this proof, you may face fines of up to €375,000 and even administrative sanctions.
3. The most common mistakes
❌ “This is for labs, not for me.”
Wrong. As soon as you create or have a custom device made, you are concerned.
❌ “A paper form is enough.”
No. Authorities require clear, structured, and secure traceability. Scattered or undated documents are no longer accepted.
❌ “I delegate it, so I’m covered.”
Also wrong. Even if handled by an assistant, legal responsibility remains with the practitioner.
4. How to stay compliant without losing time
This is where OrthoTrack (for orthodontists) and DentoTrack (for dentists) come in.
These digital solutions turn a regulatory burden into a simple, automated process:
🖥️ Automatically generated certificates for each CMD
📂 Secure archiving for 10 years, compliant with European requirements
🔗 Full compatibility with your software and digital equipment
👩🏻⚕️ One subscription for the entire practice: practitioners and assistants included
5. Key takeaways
✓ MDR = mandatory traceability
✓ You are a manufacturer as soon as you create or have a device made
✓ Without proof, you face legal and financial risks
✓ With OrthoTrack & DentoTrack, compliance becomes automatic
🔒 Protect your practice, your patients, and your peace of mind
OrthoTrack & DentoTrack — your regulatory partners, every day.
