Regulation for in vitro diagnostics (IVDs) in Europe moves into as bureaucracy swells the draft directive
This article was originally published in Clinica
Executive Summary
A pan-European system for the regulation of in vitro diagnostics (IVDs) is finally in sight. In mid-June the European Parliament will give the draft IVD directive, which European Union ministers finally agreed last November, its second reading. Consultant Maurizio Suppo takes a look at the proposals which will change the way IVD manufacturers do business in Europe.