medical device manufacturers are looking for clarity from regulators on what
exactly is required of them, while still trying to interpret what guidance has
already been released. One thing is clear though – UDI projects need to be starting now, to have any hope of meeting
the expected timelines – despite not having all the information yet.
greatest challenge of all is sure to be the sheer scale of building and
maintaining a database that is capable of efficiently cleansing and validating
UDI data while being able to submit to multiple different international
datapools with their own requirements and standards – effective master data management with a view to global UDI compliance
is truly an enormous task.
European UDI Forum seeks to help provide answers to many of these challenges by
uniting all the key stakeholders in the
healthcare ecosystem – device manufacturers, healthcare providers,
regulators, classification organisations, UDI agencies, data standards bodies
and technology solution providers. There
is truly no other meeting like it in Europe; if you’re facing UDI compliance,
you should be at this forum.