RECOPS (Registro de Comercialización de Productos Sanitarios) is the database operated by the Spanish Agency of Medicines and Medical Devices (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) for the registration of medical devices and in vitro diagnostic medical devices (IVDs) intended for marketing […]
Read More… from RECOPS: Spain’s Medical Device Commercialisation Register
Since the entry into force of Regulation (EU) 2021/2226 at the beginning of 2022, manufacturers have been permitted, under certain conditions, to provide instructions for use for medical devices in electronic form (eIFU). With Regulation (EU) 2025/1234, the European Commission has further developed the original framework […]
Read More… from eIFU Requirements: What Manufacturers and Providers Need to Consider
At first glance, the idea of a globally harmonized UDI system seems logical. Uniform identifiers, standardized data, and clearly structured processes should simplify the international trade of medical devices while strengthening patient safety. In reality, however, a far more complex picture emerges. […]
How to Achieve UDI Compliance and Manage UDI Data Correctly, Consistently, and in an Audit-Ready Manner, and Avoid Common Upload Errors
The UDI upload to EUDAMED may seem like a final step, but it is one of the most critical steps in the entire MDR and IVDR process. Incorrect data, unclear responsibilities, or manual workflows can […]
Read More… from Whitepaper: EUDAMED UDI Compliance – Simple and Audit Proof
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 Submission Software – 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