Research focus areas of CORS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

CORS funded project in collaboration with funding partner Novo Nordisk A/S

CORS staff involved: Mathias Møllebæk (PhD), Christine E. Hallgreen

 

 

The project aims at exploring the feasibility, sustainability and usability of creating and maintaining a regulatory science database, that collects in a (semi-) automated manner unstructured data from publicly available regulatory resources and transforms them in structured data ready to be sequentially analysed. The database will support the development of both a publicly available user interface to conduct (near) real-time descriptive analytics of regulatory process and output indicators, and an updated database for hypothesis-driven regulatory science studies in the functioning of the regulatory system.

The pilot project will focus on two use cases: Characteristics and follow-up of agreed Pediatric investigation plans in the EU; and description and follow-up of medicine-related safety issues evaluated in Pharmacovigilance Risk Assessment Committee (PRAC) – mapping PRAC safety evaluation process. The two use cases allow the exploration of two different phases of the drug life-cycle. This pilot project will provide a proof of concept for the creation of a regulatory science database.  The intent is to further expand the database to include additional regulatory domains as well as additional regulatory regions. Overall, the goal is for the database to provide a basis for regulatory science studies, that can improve our understanding of whether regulatory instruments are having their intended impact and can help identify areas for improvement.

CORS funded project in collaboration with funding partner Novo Nordisk A/S

CORS staff involved: Mohnish Pandey (PhD), Christine E. Hallgreen