Ivd directive 9879ec excerpts related to the requirement for traceability annex i. Hpra guide for manufacturers of general class in vitro diagnostic medical devices surg00081 444 manufacturer the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name. The eu has published a new ivd regulation which will replace the current directive 9879ec on invitro diagnostic medical devices ivdd from around 2016. Definitions definitions that do not indicate they are set out in the health products act act or health products medical devices regulations 2010 regulations are intended as guidance in this document. The new in vitro diagnostic regulation ivdr was officially passed by the eu parliament on april 4, 2017, which includes changes to strengthen the effect of legislation and better address ivd safety. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. The third and most recent directive is the ivd directive 9879ec, which was approved in 1998.
The term initially used was ec mark and it was officially replaced by ce marking in the directive 9368eec in 1993. The aim of this recommendation is to define modalities for the verification of manufactured products as required by annex iv 6 and vii 5 of the ivd directive. Requirements for labelling, instructions for use and language. The last in a series of important directives that affect laboratory medicine is the directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices, in short the ivd directive. Jan 27, 2015 you can place a ce mark on your product to show that the medical device has met the requirements when you have passed the conformity assessment, assessment routes. Manufacturers who implement the processes and documentation steps defined in the calibration traceability standards are entitled to a presumption of conformity to this essential requirement of the ivd directive. The tga is developing guidance specific for ivds as part of the australian regulatory guidelines for medical devices argmd. This directive shall apply to in vitro diagnostic medical devices and their accessories.
Ivdr device manufacturers now have five years, until 2022, to be fully compliant with all changes set forth within the new regulation. Cemarking of established ivd devices page 26 vdtuevdocument dn. The maxwell 16 ivd instrument is not intended for use as part of a specific in vitro diagnostic test. An invitro diagnostic ivd device usually comprises pathology tests and related instrumentation used to conduct testing on human bodily fluids or tissue samples to assist in clinical diagnosis. The new eu ivd regulation will cover all devices that are placed on the market from the moment it is applicable. After december 7, 2003, in vitro diagnostic products offered for sale in eu member countries must conform to ivd directive requirements and be ce. Ivd guidance documents therapeutic goods administration tga. Apr 22, 2014 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. According to the ivd medical devices directive 9879ec related to magnetic immunoassay analyzer products. Invitro diagnostic ivd products require translation. Whats changed compared to the ivdd the new eu in vitro diagnostics regulation eu ivdr is not radically different from the current ivd directive ivdd.
The pfa100 system is available for sale in the us and complies to the ivd directive 9879ec. For all devices referred to in list a in annex ii other than those intended for performance evaluation, the manufacturer shall, in order to affix the ce marking either. Revisions to the ivd directive public consultation on technical aspects of the revision of the in vitro diagnostic medical device directive june 29 september 15, 2010 issues raised inhouse tests genetic tests with without direct or indirect medical purpose directtoconsumer genetic tests. Thats not to underestimate the amount of work that will be required to switch from the current ivdd to the new eu ivdr. The directive see also regulation 2 defines an ivd as.
For ivds these requirements can be found in directive 9879ec, article 8. A medical devices technical documentation is an integral part of its regulatory approval. The letters ce are the abbreviation of french phrase conformite europeene which literaturely means european conformity. This includes the physical address of the manufacturer. The previous ivd directive ivdd 9879ec which became mandatory in december 2003 provided regulatory requirements that facilitated free trade within the eu and eea. Verification of manufactured products for the ivd directive. Ce marking ce mark for in vitro diagnostic medical devices. Regulatory and legal requirements applied to ivds are set within the changing landscape. Guidance document labelling of in vitro diagnostic devices published by authority of the minister of health date adopted 20160422 effective date 20160422 health products and food branch. Ivds are medical devices instruments, reagents and systems used to determine medical information for the diagnosis of a disease or condition. Surg0008 guide for manufacturers of general class invitro.
Ivd manufacturers need the knowledge to make decisions on the conformity route they take to comply with 9879ec and, where. Directive 9879ec on in vitro diagnostic medical devices ivdd provides the regulatory framework for manufacturers and for authorised representatives who wish to place in vitro diagnostic ivd products on the eu common market. Advance directive is the general term that refers to the various documents that could include a living will, instruction directive, health care proxy or health care power of attorney. Update to ivd directive please note the ivd directive 9879ec and common technical specifications have been amended. The pfa100 system is available for sale in the us and complies to the ivd directive 98. 98 en official journal of the european communities l 3311 i acts whose publication is obligatory 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. Dec 18, 2014 guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic ivd devices, including blood glucose meters. The eu ivd directive 9879 ec a users point of view. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents. This document applies to all medical devices, including in vitro diagnostic medical devices. Guide on ivdin vitro diagnostic medical devices ce marking. 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. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.
Diagnostic results obtained using nucleic acid purified with this system must be interpreted in conjunction with other clinical or laboratory. Guidance document labelling of in vitro diagnostic devices published by authority of the minister of health date adopted 20160422 effective date 20160422 health products and. Annex iv 6 and vii 5 of the ivd directive do not define how the verification of manufactured products should be performed. Products that satisfy the regulatory requirements are permitted to carry the ce ivd mark. The ivd directive and availability of reference systems for. To make things a little confusing, states use various terms to describe their advance directive forms.
L 117176 en official jour nal of the european union. Edma guidance on edma symbols for ivd reagents components the use of symbols as an alternative to language is recommended in the ivd directive. However, a fundamental revision of that directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation. Every medical device and ivd must be provided with a label. Variant creutzfeldtjakob disease vcjd assays for blood screening, diagnosis and confirmation are now classed as an annex ii list a device. The transition period for complying with the directive began june 7, 2002, and ends december 7, 2003. Similar to the medical device directive mdd, the ivd directive ivdd 9879ec. Implementation of the ivd directive hold potential to boost sales opportunities in europe by harmonizing regulations throughout europe, the in vitro diagnostics directive ivdd will allow manufacturers to seize sales opportunities across the continent and may encourage those that have not previously exported. Legislation in progress medical devices and in vitro. 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. In vitro diagnostic for medical devices ivd notified body. The traceability of values assigned to calibrators andor control materials must be assured through available reference measurement procedures andor available reference materials of a higher order. Jan 17, 2020 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.
740 1151 596 780 985 137 593 1281 459 1283 1263 1271 40 1496 86 9 544 1626 429 258 1259 1079 981 161 583 251 456 131 557 584 380 131 493 591 1183 1227 181 756 1129 707