Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders.

ABSTRACT:

Background

Medical device certification has undergone significant changes in recent years. However, exploration of stakeholder experiences remains relatively limited, particularly in the context of software as a medical device. This study sought to explore stakeholder experiences of medical device certification across both the UK and EU.

Methods

Semi-structured interviews (n = 22) analysed using inductive-thematic analysis, synthesised using activity theory.

Results

Innovators, consultants and notified bodies share more similarities than differences when discussing barriers and enablers to achieving medical device certification. Systemic tensions between existing rules, tools, community understanding and division of labour currently undermine the intended aim of certi

SUBMITTER: Baines R 

PROVIDER: S-EPMC9531632 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature