Product status
Medical devices are assessed under the applicable EU device rules. The classification and conformity documents depend on the precise dental reference and intended use.
Product compliance
The product.
The route.
The responsibility.
The same checks do not fit every product. Device status, documentation and the intended destination are considered before a quotation.
PRODUCT ENQUIRY↗
Reference.
Documentation.
Supply route.
Checked for the exact product
and the intended destination.
Before a quotation
Start with the exact reference.
A brand name or a congress listing is not proof of lawful supply.
Supply route
The supplying operator is identified inside the EU. Relevant product documents, labelling and instructions are checked for the reference; an appointment by the manufacturer is not implied.
Destination
The practice’s eligibility and the national conditions for supply and use matter. Swiss enquiries require a separate review of the product and import route. No supply to Romania.
Outside this service
No medicinal products, including dental anaesthetics. A product classified as a medicine in the destination country is not supplied.
Roles in the chain
Each operator has a role.
A manufacturer’s obligations do not remove the distributor’s own duties.
Manufacturer
Product conformity, the applicable conformity assessment, technical documentation, labelling, instructions and post-market obligations.
Supplying operator
The obligations attached to its own role, together with the supply records and the handling conditions applicable to the goods it dispatches.
MaxMed Systems
Distributor duties when supplying devices: the required checks, traceability, appropriate handling arrangements and cooperation on complaints, incidents and recalls.
Your practice
Professional entitlement, the national rules governing use, correct storage after receipt and the records and patient information required for the device concerned.
Documentation pathway
Know what to ask for.
Know what it establishes.
Reference and eligibility
The product reference, supply route, destination and the documents relevant to a lawful offer are reviewed. If the necessary information cannot be established, the request does not proceed.
Manufacturer’s information
Original packaging, lot and expiry information, the UDI where applicable, and instructions for use. Implant information is supplied where required and provided by the manufacturer.
Conformity documents
For devices, copies of the EU declaration of conformity and relevant certificate are requested through the supply chain. A general corporate certificate is not a substitute for product documentation.
EUDAMED is one check
Use the device identifier and manufacturer details to search the relevant EUDAMED module. Registration is not a guarantee that an individual box is genuine, and transitional registration rules can affect search results.
Open EUDAMEDPackaging and handling
Check the packaging, seals, lot, expiry and instructions on arrival. Transport and storage follow the manufacturer’s requirements. I do not promise pre-dispatch photographs or authentication of a lot by a manufacturer on demand.
If something is wrong
Raise it.
Keep a written record.
Do not use a product you suspect may be falsified or unsuitable. Follow your national reporting requirements and contact me with the order reference, product and lot.
A traceable response
I promptly forward suspected device incidents to the manufacturer and, where applicable, its authorised representative and importer. I also inform the competent authorities where required and cooperate on corrective action and recalls. Safety notices are passed to affected practices.
The shelf-life and authenticity commitments are in the General Terms. A concern is assessed on the evidence; a low price or a database result alone does not establish authenticity.
Write about a product concernNeed a specific document?
Name the product.
I will review the request.
Include the reference and delivery country so the right documentation can be identified.