EUDAMED · MDR · UDI/Devices EUDAMED: Which certificates must be provided during UDI device registration? Technical article · Last updated: 6 October 2026 Medical device manufacturers may hold several certificates…
Calculate GTIN-14, GMN, Master UDI-DI and HIBC Basic UDI-DI directly in your browser Correctly creating UDI identifiers is one of the fundamental tasks in UDI data management. Depending on the…
Last updated: 30 September 2026 The Master UDI-DI groups specified highly individualised medical devices according to relevant design parameters. It reduces the number of identifiers to be registered in EUDAMED…
Must a Swiss hospital or medical practice register a CE-compliant medical device in swissdamed if it is sourced directly from the EU? Not automatically. The decisive factor is not the…
Regulatory software creates the greatest value not by offering as many functions as possible, but by supporting a specific process reliably, transparently and with clear responsibilities. A recent article by…
Easily synchronise EUDAMED data with swissdamed: when manual XML export reaches its limits Export as XML, import into swissdamed – done. This is how many manufacturers and CH-REPs imagine transferring…
EUDAMED & HIBCC: Does the Plus Sign Belong in the UDI-DI? An analysis of more than 3 million EUDAMED records reveals a surprising inconsistency in HIBCC UDI-DIs. Since 28 May…
FDA ESG and Health Canada CESG: how medical device submissions have been transmitted electronically since April 2026 Existing FDA Gateway accounts can generally also be used for submissions to Health…
EUDAMED: Manufacturers to Upload SSCP and SSP Documents Themselves in Future With its position paper MDCG 2026-4, the Medical Device Coordination Group has announced a significant change to the management…
swissdamed Deadlines and Registration Fees: Key Clarifications from Swissmedic Do manufacturers have to pay again every year for the same UDI-DI? Does it matter whether a product was registered before…