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In vitro diagnostic medical devices directive

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  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Scope

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.

‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

concerning a physiological or pathological state, or

concerning a congenital abnormality, or

to determine the safety and compatibility with potential recipients, or

to monitor therapeutic measures.

Definitions:

‘accessory’ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose. For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;

  Description

The safety and performance of in vitro diagnostic devices are regulated in the EU by the 1998 In Vitro Diagnostic Medical Devices Directive (IVDD). This sets a framework for manufacturers and for authorised representatives who seek to place IVD products on EU market. It aims to ensure that IVD devices comply with stringent standards for quality and safety, and produce reliable data to be used for diagnostic purposes.

The IVDD lays down a series of essential requirements to ensure the efficacy, quality and safety of products. It requires that the safety and health of patients, users, and any third party must not be endangered by proper use of the product, and that any possible product risk, compared with the associated benefit, is acceptable.

The principle of integrated safety applies, which means risk avoidance and risk minimisation in the design and manufacture of the product, protective measures against residual risks, and appropriate information of users. The generally acknowledged state of the art must be applied.

  Harmonised standards

EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd...
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN 12322:1999/A1:2001 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Show all the standards...
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-1:2001/AC:2006
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-2:2015
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...
EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
EN ISO 11137-2:2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
EN ISO 11737-2:2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in...
EN 12322:1999
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for cult...
EN 12322:1999/A1:2001
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for cult...
EN ISO 13408-1:2015
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, includi...
EN ISO 13408-2:2011
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Show all the standards...

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