# Ivd directive 98/79/ec pdf **<br>Rating: 4.3 / 5 (3884 votes)<br>Downloads: 39612<br><br><a href="https://ciric.myvroom.fr/NFNJp8?keyword=ivd+directive+98%2f79%2fec+pdf">CLICK HERE TO DOWNLOAD</a>**<br><br><br><br><br><br><br><br><br><br> This can integrate into a manufacturer’s existing system and processes to meet the additional regulatory requirements and ensure device compliance Directive (98/79/EC) The In Vitro Diagnostic Directive (IVDD)/79/EC was introduced in the later part of and compliance became mandatory on ember 7, The Directive provides regulatory requirements that facilitate the free trade within the European Economic Area (EEA), which comprises theEuropean Union (EU) member In areas where no harmonised EC Directive/79/EC (hereafter abbreviated as/79/EC) represents a robust and workable regulatory framework based on ISO for quality system compliance. The purpose of this white paper is to provide an introduction to the European Union’s EC Directive/79/EC on in vitro diagnostic medical devices (IVDs). This document is not replace the existing medical devices Directive (93/42/EEC) (MDD), the active implantable medical devices Directive (90//EEC) (AIMDD) and the in vitro diagnostic medical Directive (98/79/EC) The In Vitro Diagnostic Directive (IVDD)/79/EC was introduced in the later part of and compliance became mandatory on ember 7, The Commission communication in the framework of the implementation of the Directive/79/EC of the European Parliament and of the Council on in vitro diagnostic medical Directive/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices.