Stop and separate
Do not use goods with a suspected authenticity, quality or sterility problem. Separate affected packs from usable stock. If a patient is affected, arrange appropriate clinical assessment; urgent care takes priority.
Product safety & reporting
Know the product.
Check the source.
Raise a concern.
Practical checks and official reporting routes for dental practices. A brand name, a CE symbol or a price alone cannot establish that an individual product is genuine.
Sources reviewed: 29 October 2026
If something seems wrong
Protect the patient.
Keep the evidence.
You do not need to prove falsification before raising a suspicion. Do not wait for a reply from MaxMed to seek care or make a required report.
Record the details
Keep the device and packaging safely. Record the product, manufacturer, reference, lot or serial number, expiry, UDI where present, invoice and supplier. Preserve photographs and relevant correspondence.
Report promptly
Use the competent authority for the country concerned and notify the manufacturer and supplier. Follow national rules and deadlines. Do not delay an initial report while collecting missing information.
European Commission directory
Find your national authority.
The Commission lists medical-device authorities and vigilance contacts across the EU. Select the country concerned and follow that authority’s current instructions.
Direct routes for Germany, Austria and Switzerland
DE · BfArM
Germany
Official medical-device incident reporting. Select the route for professional users.
Open official source ↗AT · BASGAustria
Medical-device reporting, including the reporting route for healthcare professionals.
Open official source ↗CH · SwissmedicSwitzerland
Swiss medical-device vigilance and professional-user reporting requirements.
Open official source ↗Verification tools
Check the reference.
Understand the limits.
Use these sources together with the manufacturer’s information and supply records. None authenticates a particular box by itself.
EU · PUBLIC DATABASE
EUDAMED
Search available device, economic-operator and certificate information. Match the exact identifiers; a database entry does not authenticate an individual pack.
Open official source EU · NOTIFIED BODIESNANDO
Check the notified body’s designation and scope. A listing identifies the body; it does not validate every certificate bearing its name.
Open official source EU · LEGISLATIONMedical Device Regulation
Read Regulation (EU) 2017/745, including Article 14 on distributor duties and the vigilance provisions. Use EUR-Lex for the current legal text and amendments.
Open official source EU · MDCG GUIDANCEGuidance & interpretation
Commission-published guidance on device rules, surveillance and vigilance. Guidance helps explain the framework; it is not a product approval.
Open official source EU · MANUFACTURER FORMSVigilance forms
Manufacturer incident-report and field safety notice templates. Clinics should follow their national professional reporting route rather than assume the manufacturer form is theirs.
Open official sourceEUDAMED: a phased system
Four modules became mandatory on 28 May 2026. Vigilance and post-market surveillance remains under development at the review date. Device and certificate registration also has transitional provisions: an absent search result alone does not establish that a product is unlawful.
Check the Commission’s current implementation guidanceBefore accepting a document
Match the manufacturer, product reference, intended purpose and certificate scope. Check the EU declaration of conformity and any certificate required for that device. Where relevant, verify applicable transition conditions. An ISO certificate, QR code or CE symbol alone is insufficient; if a document is doubtful, seek confirmation through the manufacturer or issuing body’s independently verified contact details.
MaxMed Systems
A documented route.
An accountable response.
Safety concerns are not treated as ordinary sales enquiries.
Before supply
I review the product reference, documentation, EU supplying operator and destination requirements. If there is reason to believe a device is non-conforming, it is not supplied until the issue is resolved.
A higher price is not evidence of authenticity or safety. Compare the exact pack, expiry, documentation, storage requirements and supply route, as well as the price.
Read the product and documentation policyIf a concern is reported
I record the concern and promptly forward suspected device incidents to the manufacturer and, where applicable, its authorised representative and importer. I cooperate with the competent authorities on reporting, corrective action and recalls as required by the distributor’s role.
Tell me the order reference, product and lot. Do not send identifiable patient records or clinical photographs by ordinary email. Contacting me does not replace reporting to the authority.
Notify MaxMed of a product concernMaxMed Systems is not a regulator, notified body or manufacturer-appointed distributor. These external links do not imply endorsement, certification or a partnership with any institution.
Suspected falsification or fraud
Health authorities.
Police where appropriate.
A safety report and a crime report serve different purposes. Suspected falsification may require both routes.
EU AGENCY
Europol
Report suspected crime to local or national police. Europol supports law enforcement; it does not take ordinary crime reports directly from the public.
Open official source INTERNATIONAL ORGANISATIONINTERPOL
For suspected international crime, contact local or national police. They can seek INTERPOL support. INTERPOL is not an EU institution or a product regulator.
Open official source COUNCIL OF EUROPEMEDICRIME Convention
A treaty addressing falsified medical products and related offences, including non-conforming medical devices. It is not a public reporting portal; national implementation applies.
Open official sourceThe Council of Europe is separate from the European Union. No institutional logos or approval seals are used here.
Choose the right system
A device is not a cosmetic.
A link is not an approval.
Safety Gate: a different scope
The EU Safety Gate covers dangerous non-food products, including cosmetics within its scope. It excludes medical devices and medicines, which have separate systems. For a device, use the national medical-device authority and vigilance route above.
Open Safety GateRead the Commission’s scope explanationProduct status comes first
Medical devices, Annex XVI products, cosmetics and medicines have different rules. A topical cosmetic is not an injectable product. MaxMed does not supply medicines, botulinum toxin or injectable hyaluronidase.
This page provides reporting and verification information. It does not certify an individual product or replace the applicable national rules.
Before your next order
Ask for the exact reference.
For a documentation enquiry, include the product, pack and delivery country. For a safety concern, use the reporting routes above without waiting for an order discussion.