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In vitro diagnostic medical devices Regulation Regulation

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  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Scope

This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.


For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.

EXCLUSIONS

This Regulation does not apply to:

  • Products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
  • Invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
  • Internationally certified reference materials;
  • Materials used for external quality assessment schemes.

DEFINITIONS

For the purposes of this Regulation, the following definitions apply:

  • ‘Medical device’ means ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745;
  • ‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software 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 on one or more of the following:
    • Concerning a physiological or pathological process or state;
    • Concerning congenital physical or mental impairments;
    • Concerning the predisposition to a medical condition or a disease;
    • To determine the safety and compatibility with potential recipients;
    • To predict treatment response or reactions;
    • To define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices

  • ‘Specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;
  • ‘Accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s);

  Description

Medical Devices Regulation (EU) 2017/745 has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to: Improve the quality, safety and reliability of medical devices placed on the European market. Strengthen transparency of information related to medical devices for consumers and practitioners. Enhance vigilance and market surveillance of devices in use. The extent to which these changes will affect your operations will depend on the type of device manufactured and the role you hold (manufacturer, importer, authorized representative). It is however anticipated that in most cases significant changes must be made to compliance process, quality management system, and technical documentation and successfully implemented, and certified as relevant to device classes and roles of your organization, before compliance with the regulations can be achieved.

  Harmonised standards

EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11135:2014/A1:2019 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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 11137-1:2015/A2:2019 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 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 11737-1:2018/A1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Show all the standards...
EN ISO 11135:2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
EN ISO 11135:2014/A1:2019
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
EN ISO 11137-1:2015/A2:2019
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
EN ISO 11737-1:2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a populat...
EN ISO 11737-1:2018/A1:2021
Sterilization of health care products - Microbiological methods - Part 1: Determination of a populat...
EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility perform...
EN ISO 13408-6:2021
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/A11:2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Show all the standards...

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