Executive Summary Turkey is developing into an important sales market for medical devices with a population of 85 million inhabitants and a growing healthcare economy. Despite economic challenges, the medical…
What is eMDR? eMDR (Electronic Medical Device Reporting) is the US FDA's electronic reporting system for vigilance cases related to medical devices. This system enables the structured and standardized reporting…
New Schedules for Unique Device Identification (UDI) in Australia The Australian Therapeutic Goods Administration (TGA) has announced the binding timetables for the implementation of the UDI requirements. The UDI system…
The introduction of the Medical Device Regulation brought about a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices.This step has been taken to improve the identification,…
On April 24, 2025, the European Commission released a new technical update for the EUDAMED test environment (Playground). Version v3.11.0 includes significant enhancements, particularly in the UDI/Devices module. Key Updates…
The Swissdamed platform continues to take shape – and with it the regulatory obligations for manufacturers and distributors of medical devices in Switzerland and Liechtenstein. A central module is now…
We are thrilled by the enormous interest in our free expert webinar on the EUDAMED database! With over 700 registrations, we clearly felt how relevant and important this topic is…
The importance of the EUDAMED packaging system for the regulation of medical devices in the EU The EUDAMED packaging system is an indispensable part of the broader EUDAMED system, which…
The EU Medical Device Regulation (MDR) introduced stricter rules and clearer responsibilities for all actors involved in the life cycle of medical devices. One area that raises particular questions is…
Since the EU Medical Device Regulation (MDR) came into force, the Unique Device Identification (UDI) system has become a cornerstone of regulatory compliance. For manufacturers of Single Use Devices (SUDs),…