Since the implementation of European Regulation 2017/745, custom-made medical devices (CMDs) produced in dental practices are strictly regulated.
Since May 2021, any dentist is considered a manufacturer as soon as they design or adapt a device for a patient. This involves specific legal responsibilities that are often underestimated.
Essential compliance… or face serious penalties
Failure to comply with CMD obligations can lead to significant consequences for practitioners:
- Traceability records and certificates of conformity: up to €375,000 in fines and 5 years of imprisonment (DGCCRF inspection).
- Archiving CMD records for 10 years: 5th class fines and administrative sanctions (ANSM inspection).
- Failure to declare as a manufacturer: legal risks in case of inspection (ANSM).
- Safety data and vigilance: obligation to respond in case of incidents (URSSAF, ANSM).
- Requests from insurance providers: non-compliance may result in denied reimbursement for patients.
Devices more common than you think
In practice, many procedures performed chairside or in an in-house lab fall under CMD regulations:
- Trays (whitening, aligners, retainers, TMJ splints)
- Surgical guides for implants
- Temporary or permanent prosthetics produced in-house
- Any custom device made directly in the mouth
As soon as a device is designed for a specific patient, based on an individual prescription, it must follow the full CMD procedure.
Three key pillars of compliance
For each CMD produced, the dentist must:
- Declare themselves as a manufacturer with ANSM
- Provide a traceability record and a certificate of conformity for each device
- Ensure documented quality monitoring and retain records for 10 years
Failing to meet any of these requirements may engage civil, criminal, or disciplinary liability.
DentoTrack: your simple and compliant solution
Designed specifically for dentists, DentoTrack is a certification and traceability software for CMDs, built to integrate regulatory requirements without complicating your daily workflow.
Developed based on real practice needs, DentoTrack allows you to:
- Generate mandatory documents in just a few clicks (certificates, traceability…)
- Centralize CMD records for each patient
- Automatically archive data for 10 years
- Easily delegate tasks to assistants while maintaining full control
Offered at €30 incl. VAT/month, with unlimited practitioners, workstations, and patients, DentoTrack is hosted on a secure healthcare server. A minimal cost compared to the legal and financial risks of non-compliance.
This article is brought to you by DentoTrack, co-founded by Dr. Quentin de Vomécourt and Julien Guth.
