New CORS Research Project Evaluating Accountability in Medical Device Regulation

Recent serious safety concerns with breast implants, hip replacements and vaginal mesh products in Europe have caused public concern about medical devices and how manufacturers and regulators are held accountable in the EU. In response, the European Commission introduced a new Medical Device Regulation (MDR) in 2017, which aims to reform the regulatory approach to balancing the need to bring new device technologies to patients with the need to protect public health. Yet, observers have argued that the MDR has not solved the underlying issues and instead introduced inappropriate and ineffective accountability requirements that place disproportionate burden on manufacturers and instill a false sense of reassurance with patients.

This project examines accountability mechanisms in the MDR and stakeholders’ perception of them within the wider context of European medical device governance. Accountability is defined in the narrow, legal-administrative sense as an institutional relation in which an agent (e.g. manufacturer) can be held to account by a forum (e.g. supervising body). Providing an analysis of medical device stakeholders’ interaction and the mechanisms that create accountability relations between them, the project asks: What are appropriate accountability mechanisms for European medical device innovation and how should they be evaluated? It employs a mixed-methods design that uses document analysis, qualitative interviews and a cross-sectional survey to integrate social network analysis, stakeholder and accountability mapping.

The project is funded by CORS in partnership with Novo Nordisk A/S.