Table 1

Overview of data sources

Data sourceDescriptionQuantity/Duration
Semi-structured interviewsAuditors, technical assessors, managers and consultants with AI and conformity-assessment experience17 interviews (60–90 min each)
Documentary materialEU MDR/IVDR texts, MedTech Europe and Team-NB reports, accreditation body statements12 documents
ObservationsConferences, panels and expert meetings on AI in conformity assessment5 events (1–2 days each)
Source(s): Authors’ own work

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