The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance to assist manufacturers in implementing master unique device identifiers (UDI-DI) for contact lens labeling. The ...
The European Commission’s Medical Device Coordination Group (MDCG) has published a position paper clarifying the timelines for manufacturers to comply with master unique device identifiers (UDI-DI) ...
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical ...
On September 24, 2013, FDA published its final rule for a system of Unique Device Identification (UDI). The rule has been a few years coming, so industry insiders that had time to get intimate with ...
Proposed changes may better align the system with international standards, though continued divergence between the UK and EU regulatory landscapes ...
Five medical device companies and a trade association asked FDA in late November for significant clarifications and improvements to an agency draft guidance on the global unique device identification ...
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