For many years, the Medical Device Directive (MDD), published on July 12, 1993, formed the regulatory basis for medical devices in the European Union. With technological progress, growing market complexity, and several serious safety incidents, it became clear that the MDD no longer met current requirements. Consequently, the EU initiated […]
Whether a small business or a global medical device manufacturer: MDR and IVDR requirements raise similar questions for most companies. How can UDI data from different systems be reliably consolidated? What steps are necessary to prepare my data for EUDAMED? And which solutions support the submission of large UDI volumes to […]
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. […] […]