Direct Links to important GMP Medical Device Guidelines
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices
This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.
This document provides guidance to the FDA
field staff on a new inspectional process that
may be used to assess a medical device
manufacturer’s compliance with the Quality
System Regulation and related regulations.
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles.
This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).