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),…
The EU has designated several UDI issuing entities (Issuing Entities) to provide manufacturers with various options for generating and managing their Unique Device Identifiers (UDIs). The currently recognized entities are:…
What is a "New Device" according to MDR and IVDR? Introduction The Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have significantly tightened…
What is an "Active Device" according to MDR and IVDR? Introduction The Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have tightened the requirements…
The live webinar has already ended, but you are very welcome to register to receive the recording and the presentation materials! The EUDAMED database plays a central role in MDR…
EUDAMED: Updated Rollout Plan for 2025-2027 Released The European Commission has released an updated EUDAMED rollout plan, introducing changes to the implementation timeline and transition periods. Companies in the MedTech…
Revolution or Hype? The MedTech industry faces the challenge of balancing regulatory requirements, efficient production processes, and innovative digital transformation. SAP serves as the backbone of IT infrastructure for many…
Latest Updates from Australia’s TGA The Australian Therapeutic Goods Administration (TGA) has made significant progress in implementing the Unique Device Identification (UDI) system for medical devices. We are pleased to…