Consequently, this regulation should be considered a lex specialis in relation to that directive. Some figures on the eu medical device sector over 500 000 types of medical and in vitro. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md. In september 2012, the european union medical device regulation eu mdr 2017745 was first proposed to address weaknesses in the existing medical device directive, which came into force in the 1990s. The regulation is written so that requirements ensuring a high level of protection of health. Medical devices directive 9342eec pdf download 10yi83. Conformity with medical device directive 9342eec is mandatory all. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. The medical device classification eu rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. Medical device according to european union medical devices directive. Revisions to the mdd 9342eec published as directive 200747ec. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in article 1 of directive 6565eec and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking.
For information about the content and availability of european standards, please contact the european standardisation organisations. First guidance on new rules for certain medical devices. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. The regulation aims to harmonise the european market for medical devices, building on the medical devices directives. Switzerland the eu single market for medical devices 2. Class i devices, that are non sterile and nonmeasuring, do not require a notified body nb. Pdf the european medical device regulation 2017745eu. The medical device directive is intended to harmonise the laws relating to medical devices within the european union. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. A medical device is defined in directive 9342eec as. New european regulation for medical devices to replace 93. The new regulation expanded the products in scope, as well as the list of regulated substances.
Regulation of medical devices in europe the role of. Consolidated medical device directive 9342eec interactive web page. Directive 9879ec on in vitro diagnostic medical devices ivds. The european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. The new regulations show a way forward towards the globalization of medical. Medical devices are defined as articles which are intended to be used for a medical purpose. New eu mdr regulations and revamp of the medical device.
The active implantable medical device directive aimdd was published in 1990 by the european commission. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal. Final version of the european medical device and ivd regulations published on 5 may 2017. Eu mdr timeline eu has entered into force, but will only apply for products as of may 26, 2020, with. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the. Other standards or procedures applied by manufacturer. Directive 200070ec of the european parliament and of the council of 16 november 2000. Regulation eu 2017745 on medical devices mdr and regulation eu 2017746 on in vitro diagnostic medical devices ivdr replace the three existing medical device directives 9342eec, 9879ec and 90385eec and came into force on 25 may 2017. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf. Same rules applied for the whole eu transposed into. The 2 main medical devices and their associated regulations are.
During this transitional period previous national regulations or the content. The regulation of medical devices in the european union. The regulation has significant economic impact on manufacturers, due to the cost of implementation of new regulations for new devices and ensuring that legacy products meet the new requirements. In vitro diagnostic medical devices are governed by directive 9879ec. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. Please note that this guide and the life cycle of a medical device only apply to legislation based on these eu directives. The eu regulation on in vitro diagnostic medical devices 2017746. Medical devices directive 9342eec european commission.
Extends the definition of medical device to include products without a medical purpose that are similar to medical devices in characteristics and. References made to the medical device directives include the council. The gsprs general safety and performance requirements. Download from the link below the mdr in the main european languages. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. This paper is primarily focused on the medical devices regulation eu mdr and the requirements of the eu mdr apply in large to the medical device industry. Medical device directive 9342eec cemarking qnet, llc. The mdr entered into force on 25 may 2017, marking the start of the transition period for manufacturers selling medical devices into europe. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.
Mdr was approved by the european parliament on april 5, 2017 and was published in the official journal of the european union on 5th may 2017. Directive on active implantable medical devices 90385eec aimd. Medical devices are products or equipment intended generally for a medical use. More information about the transition can be found here. The medical device regulation mdr has entered into force on may 26th 2017.
Mdd 200747eec medical device directive labeling changes. Directive on invitro diagnostic medical devices 9879eec ivdd. B regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec text with eea relevance oj l 117, 5. The medical devices directive mdd applies to all general medical devices not covered by the active implantable medical devices directive or the in vitro diagnostic medical devices directive.
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. In order to obtain medical device approval in the eu, medical devices must be correctly classified. European medical device directive essential requirements checklist page 8 of 22. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices. For a manufacturer to legally place a medical device on the european market the requirements of the directive have to be met and a ce mark applied. Directive whereas certain medical devices are intended to administer medicinal products within. How the new eu medical device regulation will disrupt and. European medical device directives the medical device directives is a new approach directive relating to the safety and performance of medical devices which were harmonized in the eu in the 1990s. Directive 9879ec of the european parliament and of the council of. The medical device regulation mdr 2017745 will replace the eus current medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. The medical purpose is assigned to a product by the manufacturer. Whereas council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 3 is the first case of application of the new approach to the field of medical devices. Youll find all those rules on the medical device regulation mdr 2017745 annex viii. The changing landscape in eu medical device requirements for more than two decades, the framework regulating medical devices in the eu has been based on two separate directives, one addressing requirements for medical devices 9342eec, also referred.
The manufacturer determines through the label, the instruction for use and the promotional material related to a given device its specific medical purpose. The directive and corresponding irish regulation define a series of rules which can be used to classify a medical device. Active implantable medical devices directive 90385eec try it for free on. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union. The medical device directive was published in 1993 by the european commission. Annex ix of the mdd defines the classification rules for europe. Council directive 9342eec of 14 june 1993 concerning medical devices. European medical device directive essential requirements. Any instrument, apparatus, appliance, material or other article, whether. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. Mdd the medical device directive is intended to harmonize the laws relating to medical devices within the european union.
As of this time the medical device regulation mdr will be the new regulatory framework which will be applicable for all medical devices placed on the market in the eu. Agreement has finally been reached over the new european union medical device regulation mdr and is expected to come into effect in june 2017. Cen, cenelec or etsi the reference of the standard and its related directive is published in the official journal series of the eu annex z of the standard details the essential requirements of the directive that are covered 17. If the appliance is at the same time a medical device within the meaning of directive 9342eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this directive. The regulation of medical devices in the european union 1.
Compliance with the revised directive became mandatory on march 21, 2010. Directorategeneral for health and food safety medical devices email webpage on medical devices. The main changes and features are that the regulation. Community rules applicable to all medical devices, this directive is. The mdr will replace the current eu s medical device directive 9342 eec and the eu s directive on active implantable medical devices 90385eec. Information about the new eu regulations mdr and ivdr can be found at this link. Information supplied by the manufacturer 30 annex ii ec declaration of conformity full quality assurance system 33 1.
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. Easy medical device is a platform for tools and resources for regulatory affairs, quality management, regualtory compliance. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards. B council directive 9342eec of 14 june 1993 concerning. The european medical device regulati on 2017745 mdr 1 passed the european parliament. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md directive. Learn how to choose your notified body or how the device regulation is different in other countries. Requirements for medical devices connected to or equipped with an energy source 29. From may 26th 2020 the medical device directive will not be valid anymore. Essential requirements checklist as per unrevised mdd mdd 9342eec eu medical device regulations. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. For the purposes of directive, the following definitions apply. Home medical device regulation and iso quality standard.
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