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Home / News Archive / News Details / Statement on reform of the EU regulatory framework for medical devices

Statement on reform of the EU regulatory framework for medical devices

Publication of a consensus statement from the EU Competent Authorities to the EU Commission

 

Competent Authorities gathered in a workshop in Utrecht, with representatives from the EU Commission participating as an observer, to reflect on the importance and means of improving the coordination and governance of the regulatory system for medical devices at EU level. During the meeting discussion were held on the need to reform the framework to address fragmentation and enhance harmonisation and effective application in practice.

With this statement, NCAs acknowledge the work undertaken by the European Commission and reaffirmed their commitment to support the cooperation on key priorities of the regulatory framework.

 

Read the consensus statement

List of endorsements