COCIR Raises Issues With UDI, AE Reports Under Proposed Regs

Important details on unique device identification, such as transition times, are missing from the EU’s draft medical device regulation, a major industry group says.

More information is needed on who will administer the UDI system, what the transition times will be for various device classes and how many entities will assign UDIs, COCIR writes in updated comments on the proposal. If this information can’t be included in the regulation, it should be clarified in the forthcoming delegated act, the group adds.

COCIR, which represents radiological and electromedical equipment makers in the EU, applauds Parliament’s recommendation for a single EU-wide UDI system and database, as well as the European Commission’s recommendation for a common UDI framework.

COCIR criticizes a proposal put forth by Parliament that would require reporting of all adverse events meeting the MDR definition of “incident,” calling it an “extreme and disproportionate expansion of the scope” of event reporting.

Adopting this provision would result in “a many hundredfold increase in the number of manufacturer reports to the electronic system,” the vast majority of which would be routine corrective maintenance calls, COCIR maintains. The group recommends retaining the current requirement to report only serious incidents.

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