Devices and software with a medical purpose sold in the EU need CE marking under MDR (Regulation 2017/745), which replaced the older MDD with stricter clinical-evidence requirements.
From our data: 19 products in our database have a CE-MDR record on file.
What changed with MDR
The regulation raised the bar for clinical evidence and post-market surveillance, and moved much medical software into higher risk classes that require a notified body rather than self-declaration. Transition periods mean some products are still sold under older certificates.
Why US buyers should care
A CE mark under MDR is independent evidence that a device has been assessed, which is useful when a product is new to the US market. It does not replace FDA clearance for sale in the United States.
More glossary terms
Ambient AI scribeBAA (Business Associate Agreement)Case acceptance rateCBCTCDT codesClearinghouseCloud PMSData conversionDeferred interestDental chartingDICOMDSO (dental service organization)ERA (electronic remittance advice)FDA 510(k) clearanceHIPAAHuman in the loopNet collection ratioOpen APIOpen vs closed architecturePeriodontal chartingPMS (practice management system)Real-time eligibilitySOC 2 Type IISoft credit checkSTL, PLY and OBJ filesTCO (total cost of ownership)Tooth surfaces and numberingWrite-back (PMS integration)