UDI Issuing Agencies
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:…
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Definition of a “New Device” under MDR and IVDR
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…
Definition of an “Active Device” under MDR and IVDR
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…
UDI EUDAMED WEBINAR
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…
TGA Australia
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…
GUDID updates
FDA Updates GUDID Guidelines: Transition to GMDN Codes Updated FDA Guidelines for the Global Unique Device Identification Database (GUDID) The U.S. Food and Drug Administration (FDA) has released a new…
Medical Devices Market in UK
Opportunities, Challenges, and Regulations The United Kingdom (UK) remains a significant market for medical devices despite its exit from the European Union (Brexit). With a growing healthcare sector, investments in…
EUDAMED Vigilance Module
We would like to inform you today about the latest developments regarding the Vigilance module in the EUDAMED database. This crucial module, scheduled to go live in 2026, will be…
Important Terms to EUDAMED
Time is running out for the medical device industry to comply with the requirements of the Medical Device Regulation (MDR). To properly implement such complex regulations, it's essential to have…
Medical Devices Market in India
Opportunities, Challenges, and Regulations India is one of the fastest-growing markets for medical devices globally. With an annual growth rate of approximately 16-17%, it presents significant opportunities for both domestic…