MDR & Compliance
Compliance built into the workflow.
Regulatory compliance in dentistry depends on structured documentation and traceability between several independent participants. Dentalinx creates those records as a by-product of normal digital work rather than as separate paperwork.
Regulation
The regulatory context
This section is modular so additional countries and regulations can be added as the ecosystem expands.
EU Medical Device Regulation (MDR)
European legislation setting requirements for medical devices, including custom-made dental devices, their documentation and traceability.
National implementation and supervision
Member states implement and supervise the regulation locally, which creates country-specific administrative expectations.
ZMedPri-1 (Slovenia)
Slovenian medical devices legislation and the obligations it places on organizations operating in the dental value chain.
JAZMP
The Slovenian national competent authority for medicinal products and medical devices.
GDPR
European data protection legislation applying to any patient-related information processed in the workflow.
Patient data protection requirements
Organizational and technical measures expected when patient-related documentation is exchanged between organizations.
Dentalinx supports organizations in meeting documentation and traceability requirements. Responsibility for regulatory compliance always remains with the organization, and nothing here constitutes legal advice or a guarantee of conformity.
Why it is difficult
Every participant owns a different part of the record
Traceability requires information that is created in four different organizations. When it is exchanged manually, the administrative work grows faster than the number of cases.
Supplier
Material information, REF and LOT data
Laboratory / PMC
Manufacturing and production records
Clinic
Incoming control, patient and treatment information
Patient
Recipient of the device and its documentation
The Dentalinx approach
Compliance as a side effect of doing the work
- Materials automatically associated with the orders they are used in
- LOT numbers associated with production records
- Laboratory documentation linked to individual cases
- MDR documents transferred to clinics with the case
- Equipment, servicing and calibration records centralized
- Vigilance workflows structured rather than ad hoc
- Audit-related records retained in a retrievable form
Dentalinx Connector
What moves between organizations
Connector is the authenticated infrastructure through which structured data is exchanged between participants.
Dentalinx Connector
Data moves between sectors · the patient is the end recipient
Dashed ring = Dentalinx Connector, the authenticated route each exchange travels
What each sector provides — and who it exchanges with
- 01
Supplier
Materials & components- Provides
- Material information · LOT · REF
- Exchanges
- PMCClinicLaboratory
- 02
Laboratory
Manufacturer of record- Provides
- Manufacturing information · MDR documentation
- Exchanges
- ClinicPMCSupplier
- 03
PMC
Printing & milling- Provides
- Production data · materials
- Exchanges
- LaboratorySupplier
- 04
Clinic
Point of care- Provides
- Patient and order information
- Exchanges
- LaboratorySupplierPatient
- ◎
Patient
End beneficiaryPlanned- Receives
- Complete case documentation
- Exchanges
- Clinic
Authentication & security
Verified organizations, controlled connections
Dentalinx verifies and authenticates organizations and users before connected data exchange is possible.
- Authenticated users
- Organizational permissions
- Role-based access
- Controlled partner connections
- Audit trails
- Data minimization
- GDPR-conscious architecture
- Secure exchange of patient-related information
International expansion
One regulation, different national implementations
EU MDR is European legislation, while implementation, supervision and administrative requirements can differ between member states. Dentalinx compliance modules are structured so they can be adapted per country.
Slovenia
ZMedPri-1 workflows — in scope
European Union
MDR baseline — in scope
Country placeholder
Reserved for future expansion
Country placeholder
Reserved for future expansion
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See compliance inside the workflow
See how Dentalinx connects laboratories, clinics and production centres through one shared infrastructure.