Devices receiving the ce mark after one successful conformity assessment procedure can be introduced into the member states of the european union and the european free. Manufacturers are free to apply to any notified body in the eu designated to carry out the desired conformity assessment procedure, regardless of which member. Manufacturers use as an input into the different parts of the technical file an essential requirements checklist and the data that they reach by using the. The european unions regulatory scheme for ivd medical devices ec directive 9879ec on ivds1 has been in place as a mandatory legal requirement since 2003, with the eus product conformity marking ce marking now permitting regulatory.
The european union in vitro diagnostics regulation of 2017. To determine shelf life, transport stability, and inuse stability, the manufacturer performs an evaluation. Europe in vitro diagnostic devices regulation ivdr ce. Update to ivd directive please note the ivd directive 9879ec and common technical specifications have been amended. The new in vitro diagnostic regulation ivdr was officially passed by the eu parliament on april 4, 2017, which includes changes to strengthen the. In vitro diagnostic medical devices internal market. Ivd software is used with or in many devices in laboratory based or point of care analysers, in handheld personal ivds, as standalone software, as software upgrades to existing systems, etc. In order to commercialize in vitro diagnostic ivd devices in the european union, a ce mark certificate is needed. Devices receiving the ce mark after one successful conformity assessment procedure can be introduced into the member states of the. 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. Guidance on the in vitro diagnostic medical devices directive 9879ec august 20. However, in parallel, the recast of all european medical device directives is. Verification of manufactured products for the ivd directive. The transition period for complying with the directive began june 7, 2002, and ends december 7, 2003.
Jul 20, 2011 the european directive 9879ec on in vitro diagnostic medical devices, or ivd directive ivdd, became operational in june 2000. The regulation is written so that requirements ensuring a high level of protection of health. At the same time, this regulation sets high standards of quality and safety for in vitro. One important aspect of the development and manufacture of in vitro diagnostic ivd medical device reagents is initially designing the stability of a product, then determining and verifying the expiry date of the product that is placed on the market.
Variant creutzfeldtjakob disease vcjd assays for blood screening, diagnosis and confirmation are now classed as an annex ii list a device. Directive 9879ec on in vitro diagnostic medical devices ivds. The previous ivd directive ivdd 9879ec which became mandatory in december 2003 provided regulatory requirements that facilitated free trade within the eu and eea. Directive 9879 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Same rules applied for the whole eu transposed into. The medical device directive,published by the european commission from the european regulatory affairs. 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. Invitro diagnostic ivd products require translation. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf, 7. Under the now phasing out invitro diagnostic directive ivdd almost 90% of ivds were able to selfcertify, similar to class i medical devices. Ivd in vitro diagnostics devices are regulated by eu directive 9879ec of 27. Certainly, for the manufacturer who produces ivds for the eu. The existing regulatory framework for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years this revision aims to overcome these flaws.
Or download the pdf of the directive or of the official journal for free this website uses cookies to ensure you get the best experience on our website. The european regulation eu 2017746 for in vitro diagnostic medical devices was published on may 5 th, 2017 and entered into force on may 25 th, 2017. The ivd sector faces significant efforts to plan for and complete before may 2022 to comply with new in vitro diagnostic regulation. Changes to the way in vitrodiagnostics medical devices are regulated in europe. The council of 5 april 2017 on in vitro diagnostic medical devices, repealing directive 9879ec and commission decision 2010227eu. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity.
However, this guideline applies to the ivd directive ivdd. In vitro diagnostic medical devices ivd are tests used on biological samples such as tissues, blood or urine to determine the status of a persons health. Revision of europes ivd directive 9879ec mddi online. The ivdd specifically addresses the safety, quality and performance of in vitro diagnostic medical devices ivds. Eu medical device and ivd regulations overview series part 1. This directive shall apply to in vitro diagnostic medical devices and their accessories. The aim of the directive was to ensure patient health and. Thats because under ivdd 9879ec, about 8090% of finished devices are not subject to notified body oversight. 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 references published under directive 9879ec on in vitro diagnostic medical devices are found in commission implementing decision eu 2020439 of 24 march 2020 oj l 90i, 25 march 2020 listed below. Examples of ivd devices include reactors, instruments, or other devices used for examining sample material from the human body, including blood and tissue samples, for the exclusive or primary purpose of providing information to ensure a correct patient diagnosis. Introduction what are in vitro diagnostic medical devices. Please find the latest consolidated ivdd 9879ec below. Classification of ivd devices conformity assessment today general ivd selfcertification by the manufacturer future. The definition of an ivd medical device in the therapeutic goods medical devices regulations 2002 includes software. Thats not to underestimate the amount of work that will be required to switch from the current ivdd to the new eu ivdr. The eus ivd directive and fda regulations in 21 cfr 809.
The eu ivd directive 9879 ec a users point of view. 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 of the population as a whole. Ce marking ce mark for in vitro diagnostic medical devices. Changes to the way in vitrodiagnostics medical devices are. Revision of europes ivd directive 9879ec ivd technology july 2011 3 based on this information, it looks rather unlikely that there will be major changes to the concepts of common technical specifications, of batch verification by notified bodies, and of quality system certification for all but the lowest class of ivds. The new eu in vitro diagnostics regulation eu ivdr is not radically different from the current ivd directive ivdd. In the case of devices covered by annex ii, list a, the manufacturer shall. Over time, there have been significant deviations from the directive, forcing a departure from the documents original objectives and goals of maintaining the health and safety of ivd devices. Software as in vitro diagnostic medical devices ivds.
Regulatory affairs professionals society download your. The ivd directive was published in 1998 by the european comission. On april 2004, the government of turkeys ministry of trade announced the implementation of twentythree european union industrial directives, which would affect an estimated 70% of the manufactured products imported into turkey. The eu ivd directive governs the safety, quality and performance of devices by setting out requirements for. Conclusion 9 even with an increasing move toward global harmonisation between the major medical device regulatory schemes of europe.
There is a broad range of ivds, from selftests for pregnancy and blood glucose monitors for diabetics, to. The regulation of medical devices in the european union. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices. In vitro diagnostic medical devices european parliament. This certification verifies that a device meets all regulatory requirements for ivds, which will soon change under the new in vitro diagnostic regulation ivdr 2017746. Just select your state from the dropdown menu below and download the free advance directive forms for you to use. Aug 29, 2017 we have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf, 7.
Verification of manufactured products for the ivd directive chapter. The chart shown illustrates the ce approval process for in vitro diagnostics ivds in europe and is available for download in pdf format. Dec 18, 2015 the european regulation eu 2017746 for in vitro diagnostic medical devices was published on may 5 th, 2017 and entered into force on may 25 th, 2017. Search for a standard by keyword or synonyms or filtering by directives. There is additional information in the eus borderline manual. Manufacturers are free to apply to any notified body in the eu designated to carry out the desired conformity assessment procedure, regardless of which member state that notified body is. Companion diagnostics and the ivd directive 9879ec. Pdf the ivd directive and availability of reference. Apr 22, 2014 the technical documentation is the proof that the device meets or exceeds the ivd directives essential requirements, it is imperative that each requirement is completely addressed.
Pdf on dec 23, 2001, neil greenberg and others published the ivd directive and availability of reference systems for ivd medical devices. 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. The third and most recent directive is the ivd directive 9879ec, which was approved in 1998. The transition to a new regulatory framework for diagnostic. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page. For the purposes of this directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. This may include reagents, instruments and specimen receptacles. The european directive 9879ec on in vitro diagnostic medical devices, or ivd directive ivdd, became operational in june 2000. If you are a manufacturer, authorised representative, importer or distributor of ivds in the eu, or a regulatory affairs or quality management professional involved with ivds, you need to know how to comply. 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. L 117176 en official jour nal of the european union.
After december 7, 2003, in vitro diagnostic products offered for sale in eu member countries must conform to ivd directive requirements and be ce. Use of symbols on labels and in labeling of in vitro. 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. With may 26 th, 2022 as the application date for the regulation eu 2017746. 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 ivd directive was amended and corrected over time. The gsprs general safety and performance requirements. When planning for your future medical care, prepare your advance directives to be sure your loved ones make health choices according to your wishes. Compose in few minutes declaration of conformity compliant with applicable directives. Ivd directive 9879ec conformity assessment annex ii list a.
Building the technical file in vitro diagnostic training. The eus ivd directive went into full effect on december 8, 2003. Please refer to our list of ce mark frequently asked questions for more detailed inquiries. Also, products which have been certified by a notified body under the ivd directive, may have up to an additional two years after 26 may 2022, during which they can continue to be placed on the market, i.