Medical Devices and In Vitro Diagnostics Regulations: publication of a consensus statement from the EU Competent Authorities to the EU Commission

National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for medical devices. This consensus statement outlines common priorities for future actions to implement and current challenges to overcome.

On July 10th, 2024, Competent Authorities as well as representatives from the EU Commission gathered in a workshop in France to discuss the implementation of the European Regulations for medical devices (2017/745) and in-vitro diagnostics devices (2017/746).

The goal was to do a state-of-play on the Regulations with the ambition to contribute to the targeted evaluation conducted by the EU Commission. It was organized at the instigation of the HMA Core Group and supported by the EU Commission.

This workshop was centred around 4 thematic pillars: Access & availability, Safety, Innovation as well as Governance & coordination that led to the drafting of a consensus statement.

With this statement, National Competent Authorities acknowledge the difficulties in the application of the regulations but wish to reiterate their confidence in the regulatory framework set out for medical devices and IVDs, underline the importance of the Regulations in the protection of public health but also outline the way forward to make the regulatory system work effectively.

National Competent Authorities remain committed to support the European Commission and work, as necessary, with key stakeholders for the effective application of the Regulations.

Link to the Consensus statement document: Medical Devices and In Vitro Diagnostics Regulations: publication of a consensus statement from the EU Competent Authorities to the EU Commission - CAMD : CAMD (camd-europe.eu)