DIGICAP held its kick-off meeting in Brussels, bringing together 19 partners from 12 European countries to start work on a common digital framework for medical device certification. The consortium gathers ten Notified Bodies, industry association MedTech Europe, research organisations RISE and VITO, legal and digitalisation experts, and SME innovation specialists.
Coordinated by TEAM-NB, the project will run for 36 months and aims to replace today’s PDF- and email-based exchanges between manufacturers and Notified Bodies with structured, machine-readable data aligned with EUDAMED.
