EU Guideline On Validating, Assessing Device Trials Overhauled
This article was originally published in SRA
Executive Summary
The European Commission has made substantial changes to its guideline on how national competent authorities should go about validating and assessing clinical investigation applications and what they should require of manufacturers under the EU directives on medical devices (93/42/EEC) and active implantable devices (90/385/EEC)1.