tracker

TQMC

TQMC has acquired wide Domain Knowledge and Experience. You can FREELY access it here and here

DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, please contact TQMC.

The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.

Sunday, April 12, 2009

medical devices

Brief Introduction of Directive 93/42/EEC Medical Devices


Directive 93/42/EEC Medical Devices 

  1. Medical Device is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
    • diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
    • investigation, replacement or modification of the anatomy or of a physiological process.
    • control of conception
  2. The following products are excluded from the scope of the Directive:
    • In vitro diagnostic devices
    • Active implantable devices covered by Directive 90/385/EEC
    • Medicinal products covered by Directive 65/65/EEC
    • Cosmetic products covered by Directive 76/768/EEC
    • Personal protective equipment covered by Directive 89/686/EEC
    • Tissues or cells of human origin
    • Viable tissue or cells of animal origin

Go To Top




SOURCE


More


Guidelines for classification of Medical Devices

Steps to take in marking of Medical Devices


EU Legislation on marking of Medical Devices

No comments:

Post a Comment