U.S. EU Agree to Work Together on UDI Standards

The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission.

The two jurisdictions will develop a plan for a bilateral test of compatibility of respective UDI databases to go with ongoing efforts within the International Medical Device Regulators Forum, according to the commission’s Executive Working Group.

Regulatory issues have taken center stage in the work of the EWG — formed in July when President Trump and EU President Jean-Claude Juncker agreed to resolve trade issues —, and a “meaningful set of short- and medium-term deliverables” were highlighted in an interim report released late last month. The report pointed to IMDRF efforts to create a globally harmonized approach to a UDI system, to facilitate the identification and tracking of medical devices.

IMDRF released preliminary guidance in August 2018 to support global convergence, covering general labeling principles for devices and IVDs, including labeling for single-use devices, software as a medical device, and devices and IVDs intended for use by lay persons. When fully implemented, the labels of most devices will include a UDI in human- and machine-readable form (IDDM, Aug. 3, 2018).

The EWG also said it would also take steps to make use of audit reports under the medical devices single audit program (MDSAP), another IMDRF initiative. The single audit program became operational in 2017. At present Australia, Brazil, Canada, Japan and the U.S are members of the MDSAP consortium.

“The EU has also indicated its readiness to negotiate an international agreement to reduce the costs of conformity assessment in transatlantic trade provided that the right conditions are met,” the EWG reported.

Read the full EWG report here: www.fdanews.com/02-14-19-EWG.pdf.