Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020. Directive 9879ec of the european parliament and of the council of. Regulation of medical devices in europe the role of. Information supplied by the manufacturer 30 annex ii ec declaration of conformity full quality assurance system 33 1. The eu regulation on in vitro diagnostic medical devices 2017746.
Essential requirements checklist as per unrevised mdd mdd 9342eec eu medical device regulations. 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. The active implantable medical device directive aimdd was published in 1990 by the european commission. Council directive 9342eec of 14 june 1993 concerning medical devices.
The european medical device regulati on 2017745 mdr 1 passed the european parliament. Consolidated medical device directive 9342eec interactive web page. For information about the content and availability of european standards, please contact the european standardisation organisations. The regulation of medical devices in the european union. Directive 200070ec of the european parliament and of the council of 16 november 2000. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. During this transitional period previous national regulations or the content.
Requirements for medical devices connected to or equipped with an energy source 29. References made to the medical device directives include the council. Consequently, this regulation should be considered a lex specialis in relation to that directive. Community rules applicable to all medical devices, this directive is. Other standards or procedures applied by manufacturer. The main changes and features are that the regulation. Extends the definition of medical device to include products without a medical purpose that are similar to medical devices in characteristics and. New eu mdr regulations and revamp of the medical device. The directive and corresponding irish regulation define a series of rules which can be used to classify a medical device. Download from the link below the mdr in the main european languages. How the new eu medical device regulation will disrupt and. The 2 main medical devices and their associated regulations are.
The mdr will replace the current eu s medical device directive 9342 eec and the eu s directive on active implantable medical devices 90385eec. Directive on active implantable medical devices 90385eec aimd. The manufacturer determines through the label, the instruction for use and the promotional material related to a given device its specific medical purpose. Directive on invitro diagnostic medical devices 9879eec ivdd. 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. The medical purpose is assigned to a product by the manufacturer. 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. Medical devices are defined as articles which are intended to be used for a medical purpose. 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. 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. Directive whereas certain medical devices are intended to administer medicinal products within. 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. The medical device directive was published in 1993 by the european commission. Switzerland the eu single market for medical devices 2.
Home medical device regulation and iso quality standard. Any instrument, apparatus, appliance, material or other article, whether. Medical devices are products or equipment intended generally for a medical use. In order to obtain medical device approval in the eu, medical devices must be correctly classified.
The new european medical device regulation mdr has been published in the official journal of the european union. First guidance on new rules for certain medical devices. Mdd 200747eec medical device directive labeling changes. Annex ix of the mdd defines the classification rules for europe. It is the responsibility of the manufacturer to classify a medical device that they intend to place on the market. Revisions to the mdd 9342eec published as directive 200747ec. The gsprs general safety and performance requirements. Pdf the european medical device regulation 2017745eu. The new regulations show a way forward towards the globalization of medical. More information about the transition can be found here. 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 regulation of medical devices in the european union 1. At that time, the manufacturers had the choice to apply either national regulation or the medical device 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. Information about the new eu regulations mdr and ivdr can be found at this link. Please note that this guide and the life cycle of a medical device only apply to legislation based on these eu directives.
Youll find all those rules on the medical device regulation mdr 2017745 annex viii. B council directive 9342eec of 14 june 1993 concerning. 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. 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. Medical devices directive 9342eec pdf download 10yi83.
From may 26th 2020 the medical device directive will not be valid anymore. Some figures on the eu medical device sector over 500 000 types of medical and in vitro. 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. The medical device directive is intended to harmonise the laws relating to medical devices within the european union. Conformity with medical device directive 9342eec is mandatory all. 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.
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 regulation is written so that requirements ensuring a high level of protection of health. Directive 9879ec on in vitro diagnostic medical devices ivds. Medical device according to european union medical devices directive. 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. Active implantable medical devices directive 90385eec try it for free on. Compliance with the revised directive became mandatory on march 21, 2010.
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. A medical device is defined in directive 9342eec as. 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. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Class i devices, that are non sterile and nonmeasuring, do not require a notified body nb. Same rules applied for the whole eu transposed into. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. In vitro diagnostic medical devices are governed by directive 9879ec. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf. New european regulation for medical devices to replace 93.
European medical device directive essential requirements. 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. The new regulation expanded the products in scope, as well as the list of regulated substances. 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. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. European medical device directive essential requirements checklist page 8 of 22. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. 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. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and.
Easy medical device is a platform for tools and resources for regulatory affairs, quality management, regualtory compliance. Agreement has finally been reached over the new european union medical device regulation mdr and is expected to come into effect in june 2017. The new europe eu medical device regulations mdr published by the european commission on may 5, 2017 revamped major portions of the eu medical device directive mdd, raising compliance bars for all device manufacturers, economic operators and notified bodies. Medical devices directive 9342eec european commission. Eu mdr timeline eu has entered into force, but will only apply for products as of may 26, 2020, with. 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. 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. 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. Directorategeneral for health and food safety medical devices email webpage on medical devices. 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. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. For the purposes of directive, the following definitions apply.
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. 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. Final version of the european medical device and ivd regulations published on 5 may 2017. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. The european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. The regulation aims to harmonise the european market for medical devices, building on the medical devices directives. Mdd the medical device directive is intended to harmonize the laws relating to medical devices within the european union.
839 1497 1644 223 1208 412 74 1117 691 1109 1365 1611 436 1065 856 28 1164 1460 327 74 561 137 744 324 1250 1070 1044 1045 1095 441 720 1189