E-labelling in the EU: will devices sector follow the IVDs?
This article was originally published in Clinica
Executive Summary
The first draft of a European IVD e-labelling guidance document should be ready for presentation to the next European Commission Medical Devices Experts Group in July. That is the hope of the European Diagnostics Manufacturers Association (EDMA) which has been working on a guidance document, along with the French, Irish and UK competent authorities.