by Innovit Corporate Affairs | Jun 18, 2025 | Blog, Eudamed
With increasing global UDI regulatory demands like EUDAMED in the EU, GUDID in the US, and now AusUDID in Australia, medical device manufacturers are under pressure to ensure timely and accurate registration of their products. While some companies manage to stay well...
by Innovit Corporate Affairs | May 12, 2025 | News
We’re pleased to share that Australia’s Unique Device Identification (UDI) regulatory framework is now officially in effect, marking a major milestone in strengthening patient safety and medical device traceability. The Therapeutic Goods Legislation Amendment...
by Innovit Corporate Affairs | Feb 12, 2025 | Blog, Eudamed
EUDAMED Go-Live Announcement – Streamlined UDI Data Submission to EUDAMED using Innovit EUDAMED Connector We’re excited to announce that Innovit’s EUDAMED Connector has been successfully implemented at B. Braun, a leading medical technology company, for UDI data...
by Innovit Corporate Affairs | Jul 10, 2024 | Blog, Eudamed
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market, are expected to usher in amendments to Regulations (EU) 2017/745 and (EU) 2017/746 expediting the use of...
by Innovit Corporate Affairs | Jul 10, 2024 | Blog
Source: EU Commission | Directorate-General for Health and Food Safety | Sante > Updated Timeline – Current planning for gradual roll out and modules’ functionality view With the Third Amendment to the European Union’s Medical Device Regulations (MDR)...
