On April 5, 2017 the European Parliament adopted two new regulations on medical and in-vitro diagnostic devices. The new EU rules focus on enhancement of patient safety and the modernization of the overall public health system.
To read the official European Commission press release click here.
- 19 Feb 2019Medical Technology Association of Australia (MTAA) releases final UDI System Proposal
- 05 Feb 2019MedTech Europe releases document on the differences in UDI requirements for the US and EU
- 29 Nov 2018HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation
- 23 Oct 2018HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th
- 16 Jul 2018Deactivation of iHIN Guest Accounts