Directive 9879eec on invitro diagnostic medical devices and the related irish regulation s. Information is also presented on how to determine if you require a notified body to assess conformity prior to affixing a ce mark. Update to ivd directive please note the ivd directive 9879ec and common technical specifications have been amended. Frequently asked questions about ce marking or questions. Medical devices quality management systems requirements for regulatory purposes iso 485. The in vitrodiagnostic medical devices directive 9879ec ivdd offers multiple routes to compliance depending on the specifications and intended purpose of use of your product. A subgroup of medical products, their market access, use, and market surveillance is regulated. In vitro diagnostic medical devices directive ce marking. The ivdd is implemented in the national laws of the member states. Directive in vitro diagnostic medical devices directive 9879ec last official journal reference wednesday 25th of march 2020 description. General requirements for in vitro diagnostic medical devices for selftesting purpose. In vitro diagnostics directive ivdd are under directive 9879ec and require a notified body ce certificate 9342eec and 9879ec ce conformity. Ivd manufacturers that need to market their devices in europe need a strategy to successfully navigate through the certification process framed by the 9879ec directive governing in vitro diagnostic medical devices similar to the medical device directive mdd, the ivd directive ivdd 9879ec, includes requirements that govern the devices performance and manufacturing, market. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices oj l 331 of 7 december 1998.
Please find the latest consolidated ivdd 9879ec below. Enterprise and industry directorategeneral machinery. This directive shall apply to in vitro diagnostic medical devices and their accessories. However, the transition may last until at least may 2024 for those ivds that are certified by a notified body under the current directive. Companion diagnostics and the ivd directive 9879ec. In europe, the invitro diagnostic devices directive 9879ec is used to regulate ivds. Enterprise and industry directorategeneral european commission scope of the machinery directive 9837ec machinery an assembly of linked parts or components, at least one of which moves, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material interchangeable equipment. Ivdd in vitro diagnostic medical devices directive mdi. Directive 9879ec of 27 october 1998, and be ce marked. Committee of competent authorities for the implementation of council directive 79831eec the 6th amendment of directive 67548eec and council directive 9232eec the 7th amendment. Medical device software software lifecycle processesiec 62304.
This sets a framework for manufacturers and for authorised representatives who seek to place ivd products on eu market. The european directive 9879ec on in vitro diagnostic. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Medical devices must be in conformity with the rules established by.
Understanding the in vitro diagnostic medical devices directive 98 79ec in vitro diagnostic medical devices ivds are subject to the european directive 9879ec ivdd. If you think you may need a notified body, whether your device. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. The ivdd aims to supplement the legal framework of the. Thats because under ivdd 9879ec, about 8090% of finished devices are not subject to. B directive 9837ec of the european parliament and of the council of 22 june 1998 on the approximation of the laws of the member states relating to machinery oj l 207, 23. Ensure your in vitro diagnostic medical device meets the essential requirements of the in vitro diagnostic directive ivdd, including quality system, design. Directive 9879ec referred to in this document as the directive. From may 2017 to may 2022, ivds will start to transition from being ce marked under the current ivd directive 9879ec to being ce marked under the new ivd regulation eu 2017746. Ivd devices in vitro diagnostics are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a test tube.
Conformity with the machinery directive became mandatory on january 1, 1995 and covers new and used machinery being placed on the market for the first time. Products that have an impact on energy consumption. It should be read in conjunction with vigilance guidance for ivds and advice for notified bodies on self tests available on the mhras website. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices the european parliament and the council of the. The current european union eu regulatory framework governing medical devices includes council directive 90385eec on active implantable medical devices and council directive 9342eec on medical devices. It also includes all the decisions taken during the meetings of competent authorities and the commission over the period 1981 to 2002 1st to 63rd. The directive on in vitro diagnostic medical devices ivdd 9879ec was officially adopted by the european union eu on december 7, 1998. The manufacturer must affix the ce marking in accordance with article 16. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. If a product uses gas, petrol, electricity, or otherwise has an impact on energy consumption during use, including parts intended for use in such product but excluding trains, cars and other means of transport, then the. Guidance explaining the main features of the in vitro diagnostic medical devices directive 9879ec.
If you use assistive technology such as a screen reader and need a version of this document. The ivd directive was amended and corrected over time. In vitro diagnostics devices ivds gmed north america. Class i 9342eec class ii 9342eec class iii 9342eec in vitro 9879ec most of gima products some gima product no products sold by gima gima tests self declaration. In vitro diagnostic medical devices are governed by directive 9879ec. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. In vitro diagnostic medical devices internal market. Variant creutzfeldtjakob disease vcjd assays for blood screening, diagnosis and confirmation are now classed as an annex ii list a device. In vitro diagnostic medical devices directive 9879ec medical devices quality management systems requirements for regulatory purposes iso 485. Since the introduction of the in vitro diagnostic directive ivdd 9879ec nearly 20 years ago, the majority of ivd manufacturers selling in europe have had it pretty easy when it comes to eu compliance. Directive 9879ec of the european parliament and of the. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices this document comes with our free notification service, good for.