While there is much uncertainty regarding the details of a unique device identification (UDI) system that is in the works in the United States and Europe, progress is being made. The International Medical Device Regulators Forum (IMDRF), which picks up where the defunct Global Harmonization Task Force left off, announced at its meeting in March that “work on the revised Unique Device Identification Draft Guidance 2.0 on labeling specifications is progressing,” writes Erik Vollebregt on his medicaldeviceslegal blog.
The European Commission (EC) added its voice to the chorus by releasing a Recommendation on 5 April calling for a common framework for a UDI system. Notably, it instructed EU member states that want to get involved in setting up such a system not to deviate from the IMDRF guidance. The EC stressed that the IMDRF document would be the only official guidance for industry pending publication of the UDI act.
In the United States, US FDA intends to present draft guidance to the IMDRF management committee by the end of November 2013. By most accounts, all stakeholders are on their best behaviour and working toward a harmonised approach.
There is always the possibility that someone will throw a spanner in the works—hopefully the EU member states will also have the patience and sang froid to not run in all directions and start to impose their own UDI systems, notes Vollebregt—but I’m going with cautious optimism for now.
This topic is almost certain to come up at forthcoming conferences on both sides of the pond: MD&M East in Philadelphia and MEDTEC UK in London. Both events feature updates on regulatory affairs led by experts in the field. MEDTEC UK will be held in London’s Olympia on 1 and 2 May. MD&M East comes to Philadelphia on 18–20 June.