On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017.
To view the EU press release click here.
- 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
- 29 May 2018Australian medical device industry bodies release joint policy paper to promote the adoption of UDI.
- 19 Mar 2018Updated HIN Submission Process effective April 1, 2018