Anyone who places a medical device on the Australian market must upload it to the Therapeutic Goods Administration (TGA) database. However, not every manufacturer has the same responsibilities. Within the AusUDID, these responsibilities depend on the company’s location. The system distinguishes between manufacturers and sponsors […]
At the beginning of August 2025, EUDAMED contained around 800,000 registered medical devices. By the time this article was published in February 2026, this number has grown to over 1.2 million devices. This corresponds to an increase of roughly 400,000 products within half a year. For comparison: the European Commission conservatively […]
Read More… from EUDAMED Long-Term Solution – mytracekey UDI Manager
At first glance, the swissdamed upload appears simple: export a file from EUDAMED and import it into the Swiss database. But is it really that straightforward? Since many of our customers must work with both EUDAMED and swissdamed, we developed an additional module for swissdamed UDI compliance. In this article, we share our key […]
Read More… from Swissdamed Upload: Learnings from Our Developers and Customers
FAQ on EUDAMED and UDI. In our webinars on EUDAMED and UDI, we receive many questions about legacy devices, the M2M interface, XML bulk upload, timelines, and responsibilities. We have collected these questions and answered the most common ones for you in this EUDAMED and UDI compliance Q&A. Over the past months, we hosted four […]
Read More… from EUDAMED & UDI FAQ – The Most Important Questions on MDR, IVDR and Legacy Devices
The UDI requirements in Australia align with two additional regulations that will require medical device manufacturers to enter their products (partially) into the respective […] […]
Read More… from UDI Requirements in Australia: TGA Guidelines, Timeline, and Labelling Obligations
(UDI) is a key requirement under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). For MedTech manufacturers, UDI compliance means correctly assigning and managing product identifiers […] […]
Read More… from What Do You Need for EUDAMED UDI Compliance?
After numerous delays, the first four modules of EUDAMED have now been audited, and their use will become mandatory in six months. This has been confirmed by the publication in the Official Journal of the […] […]
By mid to late November, the European Database on Medical Devices (EUDAMED) is expected to be officially declared “fully functional.” For manufacturers, this means the UDI registration process is becoming a reality. […] […]
Under the EU Medical Device Regulation (MDR), vigilance plays a key role in patient safety and transparency in the MedTech industry. EUDAMED serves as the central platform for submitting these reports. […] […]
Read More… from Vigilance Reporting in EUDAMED: An Overview for Medical Device Manufacturers
Authorized Representatives (ARs) carry significant responsibility toward their clients and actively contribute to traceability and product safety through collaboration with stakeholders such as importers. In this FAQ, we clarify responsibilities under MDR and […] […]
Read More… from FAQ: Authorized Representatives – Managing EUDAMED UDI Data