EC discusses role of IVDD in regulating software - before revision
This article was originally published in Clinica
Executive Summary
The European Commission is looking at streamlining regulatory provisions applicable to medical software before the drafting of an Interpretative Document. This is to ensure more clarity, especially when it comes to the issue of whether software should also be covered by the IVD Directive (IVDD) (98/79/EC). The commission plans to do this soon, well ahead of the implementation of the revision of the IVDD, which is not expected before 2015.