Qualification and classification of stand alone software. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices oj l 331, 7. Medical devices directive 9342eec and ivd directive 9879ec will be repealed and will no longer apply in the eu. How device categories class b and generic device groups class c are described can have a significant. Expectations for compliance with traceability requirements. European ce technical file or design dossier compilation. The eu ivd directive 9879 ec a users point of view article downloaded from the directive was developed over several years and is still not easy to comprehend in all its details. All devices, including ivd medical devices, should meet the essential principles of safety and performance requirement described in section i. A bsi guide to the in vitro diagnostic directive introduction in vitro diagnostics ivd is an essential and fast growing part of the global healthcare system, as they add value to patients, medical professionals and the industry along with enhancing the wellbeing. Contents of technical documentation for mdd 9342eec and. However, a fundamental revision of that directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical. The regulation is written so that requirements ensuring a high level of protection of health. An overview of how the fda regulates in vitro diagnostic products ivd. The eu ivd directive 9879 ec a users point of view article downloaded from.
Applicable to all member states sets certain aims, requirements and concrete results that must be achieved in every member state sets a process for it to be implemented by member states national authorities must create or adapt their legislation to meet these aims by the date specified in each given directive eu regulation. The heart of the european union eu regulation of in vitro diagnostic medical devices ivds lies in allowing market access to ivds that offer clinical benefit, and are safe to the patient, the user of the ivd and others such as service technicians. Directive is to ensure that ivds do not compromise the health. Class i devices, that are non sterile and nonmeasuring, do not require a notified body nb. In vitro diagnostic for medical devices ivd notified body. Medical devices other than ivd medical devices should meet the device safety and.
This directive shall apply to in vitro diagnostic medical devices and their accessories. From directives to regulation 1 public consultation recast 2008. Pdf files and attachments should not be file protected or locked as this. A medical devices technical documentation is an integral part of its regulatory approval. A new in vitro diagnostic devices regulation ivdr has been proposed to replace the existing in vitro diagnostic devices directive. The chart shown illustrates the ce approval process for in vitro diagnostics ivds in europe and is available for download in pdf format. How to plan for the eus new in vitro diagnostic regulations. Building the technical file in vitro diagnostic training. European directive ce 2017 2022 new european ivd regulation exit the european ivd directive. In vitro diagnostic mdd directive 9879ec regulation 2017745 regulation 2017746 fromdirectives to. March 2018 what does medical device clinical performance stands for. The ivd directive will soon be replaced by the ivd regulation and this is a list of web links and documents that may be useful to address the regulations both now and in the future. The ivdr definitions section does not include the term technical documentation.
Accessories to medical devices are classified separately. Directive 9879 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. The regulation eu 2017746 for ivd devices about the training the european regulation eu 2017746 for in vitro diagnostic medical devices was published on may 5th, 2017 and entered into force on may 25th, 2017. Supply of instructions for use ifu and other information for invitro diagnostic ivd medical devices a guide for manufacturers and notified bodies note this guideline is part of a set relating to the application of ec directive 9879ec on in vitro. General classification system for ivd medical devices general principles regulatory controls are intended to safeguard the health and safety of patients, users and other persons by ensuring that manufacturers of ivd medical devices follow specified procedures during design, manufacture and. Sampling of class b and c ivds under ivd regulation 2017. Standardised regulation of, and access to, ivds throughout those countries in the eu single market. Guideline for registration of medical devices 2 this guideline consists of six sections, five annexes. The gsprs general safety and performance requirements.
Ivd 0300 reagents, reagent products and devices for selfdiagnosis, including related calibrators and control full quality assurance system annex iv annex vii creation date. Background to european ivd regulation ivd directive 9879ec came into force in 2003. Directive 9879ec referred to in this document as the directive. Assists sponsors who are planning to develop a therapeutic product for which the use of an in vitro companion diagnostic device or test is essential, and. After a stepwise introductory period of five years it will come into full power for placing on the market by december 7, 2003 with all its rules and amendments.
The directive see also regulation 2 defines an ivd as. Ivddirective working group reports to quality and regulations committee committee chair. Amended once to include vcjd in the high risk group of ivd analytes ivd regulation 2017746 issued in 2017 and will replace the ivdd in 2022. Proof as to how requirements of en 641 have been implemented. If an ivd is designed to be used in combination with other ivds, non ivd medical devices, or accessories to medical devices, each device must be classified separately. In vitro companion diagnostic devices guidance for.
Devicespecific guidance for manufacturers on reporting adverse incidents under the european vigilance system ivd blood glucose meters poct or home use to be read in conjunction with the european commissions guidelines on a medical devices vigilance system meddev 2. The european directive 9879ec on in vitro diagnostic medical devices, or ivd directive. However, in parallel, the recast of all european medical device directives is being prepared. Journal of medical device regulation august 2010 15 any malfunction or deterioration in the. Similar to the medical device directive mdd, the ivd directive ivdd 9879ec. As of that date, ivd products marketed in the eu must comply with the ivd directive and bear the ce mark mark showing that the product is certified for sale in the european community to indicate compliance. The aim of the in vitro diagnostic directive 9879ec in vitro diagnostics ivd is an essential and fast growing part of the global healthcare system, which add value to patients, medical professionals and the industry as well as enhancing the wellbeing of the population as a whole. 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. Device class class c class b ass technical file assessment by ref laborato manufacturer ec declaration of conformity technical file update file.
The eus ivd directive and fda regulations in 21 cfr 809. Ivds according to the directive, in vitro diagnostic medical devices include. The directive references ce marking as per eu decision 7682008, annex ii, module a but that was not clear enough en50581 guidance document was released to clarify technical files requirements related to rohs directive 201165eu 6 rohs. It outlines the obligations of the manufacturer and the performance of laboratory instruments and reagents in general terms. Eu medical device and ivd regulations overview series part 1. From one medical device manufacturer to another, from one notified body to a medical device manufacturer or from one competent authority to a medical device manufacturer, from standards to standards or regulations, the word performance can be used in a wide different way. Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices. Eu substances regulation applicable to medical devices and ivds an overview of everything you need to know about eu legislation restricting hazardous substances from use in medical and ivd devices placed on the market in eu member states.
Use of symbols on labels and in labeling of in vitro. Devicespecific guidance for manufacturers on reporting. Ivd regulation 2017746 regulation eu 2017746 on in vitro diagnostic medical devices and repealing directive 9879ec and commission decision. This document outlines the current controls on the sale and supply of in vitro diagnostic ivd medical devices and explains the main features of the in vitro diagnostic medical devices directive 9879ec referred to in this document as the directive. L 117176 en official jour nal of the european union. It should be read in conjunction with vigilance guidance for ivds and advice for notified bodies on self tests available on the mhras website.
The eu ivd directive 9879 ec a users point of view. Medical device manufacturers need to be in full compliance with the new regulation by may 26, 2020. Annex ix of the mdd defines the classification rules for europe. Analysis and interpretation of the optical density delivered by an elisa reader, line or spot pattern of a blot. Nbog documents for medical device directives 90385eec, 9342eec and 9879ec. In house manufacture as you probably know the in vitro diagnostic medical devices directive ivdd came into force on 7 december 2000 provisions to be applied from 7 june 2000, with a transition period which ends on 7 december this year in respect of new devices being placed on the market. Changes to the way in vitrodiagnostics medical devices are. Hereby this technical file to be a statement of magnetic immunoassay analyzer and manufacturing process are functional and with well quality. In vitro diagnostic mdd directive 9879ec regulation 2017745 regulation 2017746. This may involve the use of laboratory tools such as primers to improve the performance of an existing ivd within a healthcare institution. The european medical device regulations 2017745 and in vitro diagnostic regulations 2017746 were entered into force on may 26, 2017. Building a technical file for ivds lnegmed america. The eus ivd directive went into full effect on december 8, 2003.
However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or. Compiling your technical file or design dossier is a critical step in europes ce marking process and a requirement for compliance with the medical devices directive 9342eec, in vitro diagnostic medical devices directive 9879ec, or active implantable medical devices directive 90385eec. Mapping out your path ahead of time, including preparing to be flexible, will equip you to respond to this new paradigm. General classification system for ivd medical devices. This technical file include thirteen chapters which illustrate manufacture, technical document, relevant test reports, certificates, package, labels and some advertising materials.
In the european union, the ivd directive that governs the regulatory market access for in vitro diagnostic medical devices, or ivds, also includes requirements for the specific devices technical documentation. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices article 1 scope, definitions 1. In the transition phase a device could be ce marked under either the current directives, or the new regulations if they are fully compliant but this is dependent on the designation of notified bodies to the new regulations. Contents of technical documentation for mdd 9342eec and ivdd 9879ec.
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