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Data Complexities with the EU UDI Regime

Data Complexities with the EU UDI Regime

A selection of experts have highlighted one key hurdle the market should brace for: data management with the EU UDI regime. Due to this area being expected to differ from the FDA’s GUDID process quite sharply in some places. With the MDR due to come into effect in a few years time, Pharma IQ gains insight on the forecasted data complexities attached to the EU’s UDI gameplan.
Filling The Gaps In Your UDI Strategy

Filling The Gaps In Your UDI Strategy

Following the demand for increased accountability and traceability with medical devices to safeguard patient safety, manufacturers must meet the expectation to bring printing, labelling technologies and master data management up to compliance standards. This will involve developing a UDI corporate strategy and policy for all business units and departments.

On the road to meeting compliance deadlines and executing a UDI project one key step will be pinpointing any gaps between existing supply chain systems to UDI requirements. This will involve analysing the supply chain process, transit issues, the mechanics of recalls and reporting on a UDI compliant product and whether the expected benefits are achieved. Then redesigning and integrating management of product labelling and packaging to enable regulatory compliance. With this large task in mind, we spoke to a couple of experts on the subject of filling the gaps within a UDI strategy. Find out more here.