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.
- 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