Health Canada CESG
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…
Category News
EUDAMED: Manufacturers take over SSCP and SSP upload
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…
Swissmedic registration fees
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…
Webinar: Global UDI 2026 – EUDAMED, swissdamed & TGA Australia
Webinar: Global UDI 2026 -EUDAMED, swissdamed & TGA Australia Deadlines, Transition Periods and Practical Upload Solutions for Small and Large Companies UDI requirements are becoming mandatory in several important markets…
Transparency in the Global Submission Portal
Greater Transparency in the Global Submission Portal: Audit Trail, UDI Publication Report and EUDAMED–swissdamed Synchronization With the Global Submission Portal, Europe IT Consulting GmbH supports medical device manufacturers in centrally…
swissdamed registration fee
New Registration Requirement for Medical Devices: What Applies from July 2026 As of July 1, 2026, medical devices on the Swiss market must be registered in the national database swissdamed.…
UDI Registration in Switzerland
swissdamed: How Europe IT Consulting Supports UDI Registration in Switzerland With swissdamed, Swissmedic is systematically expanding the national database for medical devices and in vitro diagnostics. For manufacturers, Swiss Authorised…
EUDAMED deadline 28 May 2026
EUDAMED deadline 28 May 2026: When a new UDI-DI brings forward the registration of the Basic UDI-DI In just a few weeks, on 28 May 2026, the use of the…
EUDAMED Status
EUDAMED Status What do Draft, Discarded, Submitted, and Registered mean for UDI data? Anyone maintaining UDI data in EUDAMED or transmitting it via XML/M2M will regularly encounter different dataset statuses.…
EUDAMED, swissdamed & AusUDID 2026
2026 increases the pressure to act for manufacturers 2026 will be operationally demanding for many MedTech companies. In the EU, the first four EUDAMED modules will become mandatory from 28…