I gave a presentation on current and future developments in UDI at the RAPS 2014 conference in Austin last week, sitting on a panel on global developments in UDI with presentations on developments also in the US and China.
This will be a short post on the subject of UDI, because most of the information will be in my presentation, which you can view right here:
As you can see in the presentation and by way of summary, the EU is not doing a lot presently pending the medical devices regulations revision process (which will feature UDI) except undertaking efforts to make sure that the individual member states do not go out on a limb and impose their own national and divergent UDI systems.
The EU will also will be vigilant not to put anything in place that is very different from what the US is putting in place because that would really drive a nasty compliance wedge in the international medical devices market.
When the regulations finally complete, UDI will be phased in for groups of devices based on their risk profile and a lot is still to be implemented by so-called delegated acts. And, of course, if and when UDI will actually work in the EU will also depend on the completion of the Eudamed cathedral.
Thanks Erik, but I don’t see a link to the RAPS presentation? Kind regards, Oliver
Sent from my iPhone
Hi Oliver, the presentation is a Slideshare embedded in the blog post – if I check it works for me. Maybe try on a different device? Otherwise let me know and I’ll send you the presentation by email. Best, Erik