- Keywords: Product Assurance
The European Commission published a new version of the “Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices”. Please click here to access the version 1.18 (12-2017) of the manual.
This manual shall only serve as “tool” for the case-by-case application of community-legislation by the member-states. It is for the national competent authorities and national courts to assess on a case-by-case basis.
The content of this manual and all updates are presented to the working group on borderline and classification for consultation. This group is chaired by the commission and is composed of representatives of all member states of EU, EFTA and other stakeholders.
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