UDI
The unique device identifier. UDI includes the device identifier UDI-DI and the production identifier UDI-PI. It supports unambiguous identification and traceability.
MDR Article 27
EU MDR 2017/745 · traceability in practice
From the label to the patient.Every step traceable.
MDR is more than the CE mark on a box. It is achain of identification and responsibility: the manufacturer assigns unique identifiers to the device, the distributor preserves the link to the specific dispatch, and the healthcare provider links the implanted device to the clinical record and, where Article 18 MDR applies, to the patient's Implant Card.
REFproductUDIidentificationLOTbatchordertransaction linkEUDAMEDEuropean registration
UDIunique device identity
IPD
manufacturer
manufacturer
Exklusiv Dent
distribution
distribution
clinic
clinical record
clinical record
Implant Card
patient
patient
EUDAMED
registration
registration
What MDR means in this workflow
Five complementary layers
The European database, UDI, production batch and commercial records are not interchangeable. Each answers a different question, and together they create practical traceability.
LOT / batch
The production identifier for a specific manufacturing batch. In practice, it is a key link for determining which batch was supplied to a specific customer.
production identityOrder and dispatch record
In the Exklusiv Dent system, these records link the customer and dispatch date to specific REF, LOT and UDI line items. The order number also provides the link to invoicing.
internal traceabilityEUDAMED
The European database on medical devices. Since 28 May 2026, the UDI/Devices module has been mandatory for the relevant registration obligations. It does not replace records of a specific distributor-to-customer transaction.
EU databaseTerminology matters
EU MDR 2017/745 is a European Union regulation, not a directive.It is directly applicable in Member States and is complemented by national legislation and procedures of the competent authorities.
Exklusiv Dent × customer traceability
How a specific device can be traced back
The practical traceability chain is based on the data Exklusiv Dent records when medical devices are dispatched: REF/code, quantity, LOT, UDI, customer and dispatch date. The customer therefore does not need to reconstruct a “black box”; one reliable starting identifier is enough.
The product arrives from IPD
The device identity is linked to the manufacturer, REF, UDI and production LOT.
Customer order
The order creates a specific commercial link between the customer and the items supplied.
Dispatch record at shipment
The dispatch record carries REF, UDI and LOT information to the customer and creates a clear verification point.
Clinical record
The treating healthcare provider links the device used to the patient and procedure date in its clinical documentation.
Retrospective traceability
Using the LOT together with a date or order number, the corresponding commercial and product data can be reconstructed.
What you can send us
A LOT number is a small field with a long memory.
If a specific item needs to be traced months or years later, the fastest route is to provide one of these identifiers. The more you have, the faster the verification.
- LOT + purchase / dispatch dateUsing internal records, we can identify the corresponding order or invoice, REF and UDI.
- Order / invoice numberIn the Exklusiv Dent system, this provides a direct link to the items supplied in that shipment.
- REF + LOTA strong combination for identifying a specific product type and its production batch.
- UDIIt allows the device to be identified unambiguously and its registration information to be compared.
Medical-device dispatch record
Anonymised example based on the document used for Exklusiv Dent shipments
| REF / code | UDI | LOT | patient / ID* |
|---|---|---|---|
| IPD-XXXX | 84355666… | A26XXXXX | ________ |
| IPD-YYYY | 84355666… | A25XXXXX | ________ |
| IPD-ZZZZ | 84355666… | A26XXXXX | ________ |
* Clinical fields are intended for linkage within the healthcare provider's records.This public example intentionally contains no real customer or patient data. For routine commercial traceability, Exklusiv Dent works with product and transaction identifiers, not with public sharing of personal health information.
A
Do you have the LOT and an approximate date?
We can trace the order or invoice and reconnect the supplied item with its REF and recorded UDI.
B
Do you have the order or dispatch-record number?
We can review the specific shipment and reconstruct its REF – UDI – LOT line items.
C
Need to verify the device in the EU?
EUDAMED is used to verify registration and identification information for a device. It does not replace our commercial traceability record.
D
Need an Implant Card?
For a device to which Article 18 applies, the digital IPD process described below can be used.
IPD update from 3 June 2026
The IPD Implant Card has moved to a digital process
IPD announced that from 3 June 2026 the Implant Card is no longer physically supplied with the product. Instead, the corresponding card can be requested through the IPD website. The request is identified usingreference + LOTordelivery-note number; after processing, IPD sends the card by email as a PDF, with a stated processing time of up to 24 hours.
1. Request
The treating healthcare provider or distributor enters the device-identification data in the IPD request.
2. IPD processing
This is not a direct search in a self-service database. The request is processed by the IPD system/team.
3. PDF by email
The corresponding document is sent electronically. It can then be completed and provided to the patient in accordance with the applicable requirements.
An important boundary of responsibility
Digital delivery of the IPD document does not change the healthcare provider's obligations under Article 18.For implantable devices to which Article 18 applies, the healthcare provider must make the required information available to the patient and provide the Implant Card completed with the patient's identity, date of implantation and identification of the healthcare institution. The official MDCG guidance also states that the patient's identity is added at the point of care.
IPD
DIGITAL IMPLANT CARDDeviceimplantable medical device
REFIPD-XXXX
UDI-DI84355666…
LOT / UDI-PIA26XXXXX
ManufacturerIPD Dental Group
Websiteipd2004.com
Completed by the healthcare provider:patient / ID · implantation date · provider name and address.
Illustration only, not an original IPD Implant Card.The fields reflect the principles of Article 18 MDR and MDCG guidance; the specific form and data must always follow the manufacturer's documentation for the device concerned.
Who is responsible for each part of the chain
Traceability works only when responsibilities remain clear
This public page therefore separates the responsibilities of the manufacturer, distributor and healthcare provider. Exklusiv Dent does not create the UDI and does not replace clinical documentation; its role is to preserve the distribution trace and connect it reliably with manufacturer data.
| Role | What it holds / provides | Practical output |
|---|---|---|
| IPD · manufacturer | Device identity, UDI, labelling, manufacturer documentation, device registration and information for implantable devices where Article 18 applies. | REF · UDI · LOT · documentation |
| Exklusiv Dent · distributor | The link between received/dispatched devices, the customer and date; verification and retention of data required for distribution traceability; assistance with traceability investigations. | order · invoice · dispatch record |
| Healthcare provider | Linking the device used to the patient and procedure, completing the clinical fields of the Implant Card and providing the required information to the patient where applicable to that device. | patient · procedure · date |
| EUDAMED | European registration and information layer for devices and economic operators within the scope of the mandatory modules. | public / device data |
Privacy: the patient is not a commercial identifier
For routine retrospective traceability at distributor level, the LOT, date, REF, UDI or order is sufficient. Patient identity belongs in the clinical record and on the card completed by the healthcare provider. This separates commercial traceability from personal health information.
EUDAMED complements, but does not replace, the dispatch record
The public database can be used to verify a device and its registration information, but it does not show which specific LOT was supplied to a particular clinic on a particular date. That link is preserved in the distributor's records.
Integrity of the stock trace
Returning a medical device must not break traceability
Exklusiv Dent's internal return rules follow a simple principle: an item may be returned to stock only when its identity and condition can be demonstrably preserved.
No loan-and-return model
For the specified medical devices, the transaction is a standard sale, not a “try and return” arrangement.
Intact packaging
A return is considered only for an unused device with an intact sterile barrier and preserved storage conditions.
The LOT remains legible
Every returned item is visually inspected and traceability of the production batch must be preserved.
Only approved items return to stock
Only approved, demonstrably unused items are returned to stock; any credit note is linked to an approved return.
Note:the 7-day time limit and specific return conditions are internal Exklusiv Dent commercial/safety rules from the supplied materials, not a general requirement stated in the MDR. Each case is assessed according to the device type, packaging condition and current Terms and Conditions.
Article 18, clearly stated
An Implant Card is not required for every component
General traceability requirements for relevant devices must not be confused with the Implant Card obligation. Article 18 MDR applies to implantable devices within its scope and also contains specific exemptions.
What the card should contain for an applicable implantable device
According to the MDR and MDCG guidance, this includes in particular the device name and type, UDI, serial number or LOT/batch, manufacturer and manufacturer website. The healthcare institution adds the patient or patient ID, implantation date and provider identification.
Article 18 exemptions
The MDR explicitly exempts from the Implant Card requirement, among other items, sutures, staples, dental fillings, dental braces, tooth crowns,screws, wedges, plates, wires, pins, clips andconnectors. It therefore cannot be assumed that every IPD prosthetic component requires an Implant Card.
Primary regulatory sources
Verifiable sources, not regulatory folklore
For the normative interpretation, refer directly to the MDR text and current sources from the European Commission and SÚKL. The internal Exklusiv Dent workflow sits alongside these sources as a practical distribution layer.
Regulation (EU) 2017/745Full legal text of the MDR on EUR-Lex.Open EUR-Lex →
UDI · European CommissionUDI-DI, UDI-PI and the role of UDI in traceability.Open source →
EUDAMEDPublic access to the European database on medical devices.Open EUDAMED →
MDCG 2019-8 v2Guidance on the Implant Card under Article 18 MDR.Open guidance →
SÚKL · distributionCurrent information on notification obligations for distributors in the Czech Republic.Open SÚKL →
Current EUDAMED status
The European Commission states that from28 May 2026the first four functional EUDAMED modules are mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates and Market Surveillance. This page was editorially updated to reflect the status in August 2026.
Practical FAQ
When you need an answer in one minute
What should I send Exklusiv Dent when I need to trace a specific item?
Ideally, send the LOT and purchase or dispatch date. Internal records can then be used to trace the corresponding order/invoice and linked REF and UDI. An order number or dispatch-record number is an equally useful starting point.
Is EUDAMED the same as our dispatch record?
No. EUDAMED is the European registration and information database. The Exklusiv Dent dispatch record preserves the specific transaction link: what was supplied, to whom, when and with which LOT/UDI. The two layers complement each other.
How do I obtain an IPD Implant Card from 3 June 2026?
According to the IPD announcement, the card is now requested electronically. The request includes the reference + LOT or the delivery-note number. IPD processes the request and sends the corresponding card by email as a PDF, with a stated processing time of up to 24 hours.
Who adds the patient information to the Implant Card?
The treating healthcare provider. MDCG guidance on Article 18 explicitly distinguishes manufacturer-supplied information from fields completed by the provider: patient/ID, implantation date and identification of the healthcare institution.
Does a fixation screw also require an Implant Card?
Article 18 MDR lists screws and connectors among the exemptions from the Implant Card requirement. This does not remove general device identification, UDI/LOT requirements or distribution traceability for the medical device concerned.
Is this page legal advice?
No. This is a professionally edited overview of the workflow and public regulatory requirements. The current MDR text, Czech law, guidance from the competent authorities, and the manufacturer's documentation and instructions for use for the specific device remain authoritative.
Need to trace a specific item?
Contact supportSend us the LOT, date or order number.
You do not need to reconstruct the entire chain yourself. If you have at least one reliable identifier, we can help connect the dispatch data with REF, LOT and UDI.
Regulatory notice:classification and obligations always relate to the specific medical device and its intended purpose. Information on this page does not replace the instructions for use, declaration of conformity, manufacturer documentation or legal advice.
