The main changes and features are that the regulation. Regulation of medical devices in europe the role of. The essential requirements of the medical device directive 9342eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1. 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. Final version of the european medical device and ivd regulations published on 5 may 2017. 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.
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. Medical device directive medical devices, including wheelchairs and scoot mobiles, must comply with the european directive for medical devices 9342eec. 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. First guidance on new rules for certain medical devices. References made to the medical device directives include the council.
In order to comply with the european union eu medical device directives 90385eec active implantable medical directives aimd, 9342eec medical device directive mdd and 9879ec in vitro diagnostics device directive ivdd referred to as the directives hereafter, manufacturers must conduct postmarket surveillance pms. She also noted that by eu mdr definition software in its own right, when specifically intended by the manufacturer to be used for one or more medical purposes set out in the definition of a medical device, does qualify as a medical device. 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.
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. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. The essential requirements of the medical device directive 9342eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. The european medical device regulati on 2017745 mdr 1 passed the european parliament. Council directive 9342eec of 14 june 1993 concerning medical devices. Medical devices are defined as articles which are intended to be used for a medical purpose. European medical device directive essential requirements checklist page 8 of 22. Directive 90385eec on active implantable medical devices directive 9342eec on medical devices regulation on medical devices directive 9879ec on in vitro diagnostic medical devices regulation on in vitro diagnostic medical devices revision of the eu medical devices legislation background 7. Jan 26, 2018 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.
The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. Some figures on the eu medical device sector over 500 000 types of medical and in vitro. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. 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. More information about the transition can be found here. The references published under directive 9342eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below. You need to demonstrate that your medical device meets the requirements in the medical devices directive mdd by carrying out a conformity assessment. 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 qualification of software, either as a device or an. An ivd medical device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to. Jan 27, 2015 you need to demonstrate that your medical device meets the requirements in the medical devices directive mdd by carrying out a conformity assessment. 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.
Medical device manufacturers were able to apply the medical device directive on january 1, 1995. International expert information for the medical device industry. B council directive 9342eec of 14 june 1993 concerning. From may 26th 2020 the medical device directive will not be valid anymore. 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. 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. The new regulations show a way forward towards the globalization of medical. It builds upon the basic medical device definition to state that. The directive and corresponding irish regulation define a series of rules which can be used to classify a medical device.
With patient health and safety as a guiding principle, the council and the parliament adopted regulation 2020561 amending regulation eu 2017745 on medical devices regarding application dates of certain of its provisions on 23 april. 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. Requirements for medical devices connected to or equipped with an energy source 29. Date of application of the medical devices regulation postponed until may 2021. Therefore i am attaching the pdfs to this posting for anyone who is.
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 to as the medical device directive, or mdd, and the second. Eu mdr timeline eu has entered into force, but will only apply for products as of may 26, 2020, with. Eu medical device directive 9342eec labelling requirements. Community rules applicable to all medical devices, this directive is. European medical device directive essential requirements. The gsprs general safety and performance requirements.
Active implantable medical devices directive 90385eec try it for free on. The new regulation expanded the products in scope, as well as the list of regulated substances. Medical devices internal market, industry, entrepreneurship. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. 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. Switzerland the eu single market for medical devices 2. The medical device directive was published in 1993 by the european commission. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. Directive 9879ec on in vitro diagnostic medical devices ivds. The regulation of medical devices in the european union 1. Pdf the european medical device regulation 2017745eu. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec.
By contrast, software for general purposes, even when used in a healthcare setting or software intended. New eu mdr regulations and revamp of the medical device directive. These products can thus only be marketed if they fulfil the essential requirements annex 1 of the directive. The regulation of medical devices in the european union. The manufacturer determines through the label, the instruction for use and the promotional material related to a given device its specific medical purpose. Learn how to choose your notified body or how the device regulation is different in other countries. How the new eu medical device regulation will disrupt and.
Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020 date of application to meet the requirements of the mdr. In order to obtain medical device approval in the eu, medical devices must be correctly classified. 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. Directive 200070ec of the european parliament and of the council of 16 november 2000. New eu mdr regulations and revamp of the medical device. European parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002. Medical devices are products or equipment intended generally for a medical use. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 5 of 22 manufacturer. I have created a new pdf version from the eu mdd 9342eec for use on mobile devices. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for. 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. Directive 9879ec of the european parliament and of the council of. Easy medical device is a platform for tools and resources for regulatory affairs, quality management, regualtory compliance. The medical device directive is intended to harmonise the laws relating to medical devices within the european union.
Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Medical devices directive 9342eec european commission. Table of contents european medical device regulation. Extends the definition of medical device to include products without a medical purpose that are similar to medical devices in characteristics and. Information supplied by the manufacturer 30 annex ii ec declaration of conformity full quality assurance system 33 1. 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. 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. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf.
Apr 12, 2020 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. Medicines can be marketed for use in combination with a medical device, usually to enable the delivery of the medicine if the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under directive 200183ec or regulation ec no 7262004. 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. Youll find all those rules on the medical device regulation mdr 2017745 annex viii.
Conformity with medical device directive 9342eec is mandatory all. The regulation is written so that requirements ensuring a high level of protection of health. Other standards or procedures applied by manufacturer. 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. Medical device directive 9342eec cemarking qnet, llc.
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. It is the responsibility of the manufacturer to classify a medical device that they intend to place on the market. 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. 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. Medical devices directive 9342eec pdf download 10yi83. 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. 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 the european parliament and the council of the european union. Consolidated medical device directive 9342eec interactive web page. Medinfo medinfo council directive 9342eec on medical devices. 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. 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. The medical purpose is assigned to a product by the manufacturer. New european regulation for medical devices to replace 93.
I have had benefit from reading several threads, downloading attachments in the elsmar forums. Home medical device regulation and iso quality standard. How the new eu medical device regulation will disrupt and transform the industry 77 economic operators in the medtech supply chain will need to hjgk kao kl%eyjcl surveillance and reporting rules t hese are transformational shifts for medtech companies, from several points of view. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens.