Abstract
The Regulation responds to legislation failures in the European regulatory framework on medical devices (MD), which in turn led to public health issues. Two media scandals triggered the final actions on the elaboration of this EU Regulation, which was already being thought off in a context of fast MD development, and on the commitment of member-states to harmonize legislation in order to better manage resources.
This Regulation is expected to address detected gaps, and contribute to the protection of European citizens' health by ensuring high quality and safety of MD, through advocating for more transparency, vigilance, and traceability. A technique to evaluate policies is the implementation analysis, as it links theory and practice. By understanding it, it is possible to ascertain if, in fact, the Regulation will contribute, as proposed, to improve public health. The implementation analysis framework I developed can be used in other countries affected by this Regulation, and may even be extrapolated to other scenarios.
Entry into force 25/05/17.Full application 05/20. This qualitative study uses document analysis and semi-structured interviews to collect data, and literature review to frame the situation and to study implementation analysis. The questions are: identify the facilitators and resistance points of the implementation; explore perceptions of the Portuguese MD distributors; understand the policy implementation pathway; and have a picture of the implementation status in Portugal.
The results can be summarized as: implementers are interested in complying with the Regulation; there is stakeholder involvement in policy making and throughout the implementation process; the main points of resistance, difficulties and the facilitators are identified; and the Regulation is being implemented according to the timelines.
The public health action brought by the policy is that each economic operator is an active actor on vigilance and patient safety across MD lifecycle.
Key messages
If we are interested in the extent to which a particular polity is able to solve the problems with which it is confronted, we need to study the way in which the law is executed in practice. Focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.
Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View
