EU IVD "Common Technical Specifications" May Spread To Certain Devices
This article was originally published in The Gray Sheet
Executive Summary
Use of the "common technical specifications" concept contained in the European Union In Vitro Diagnostics Directive could spread to certain high-risk medical devices, undermining the principle of device manufacturer self-regulation in the EU, according to Richard Moore, director-business area, European Confederation of Medical Devices Associations (EUCOMED).