Executive ARC

In limited occasions, the ARC Board has issued Executive documents, that encompass views from the Board. The ARC Governance Charter sets the background and processes involved in this collaborative effort. The successful completion and subsequent implementation of ARC definitions and standards relates to the timely implementation of the process that operates under the umbrella of ARC. A second Executive document refers to the Board’s views on assessment of device and procedure relatedness assessments when reporting adverse events. This is a recurrent topic in all areas and is meant as guidance with general principles to achieve a consistent approach when it comes to relatedness assessments.