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 ivdd is implemented in the national laws of the member states. The european unions eu medical device regulation mdr and in vitro diagnostic regulation ivdr, originally published on 05 may 2017 by the eu parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the eu. The new mdr medical device regulation 2017745 is set to replace the existing national requirements of the medical device directive mdd 9342eec within a specified time frame. In vitro diagnostic medical devices directive 9879ec. Medical device ce marking service covering reusable medical devices, equipment, disposables, implants, drug device combination, and home healthcare devices across all classes spanning a diverse range of indications. Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for. Eu medical device regulation mdr 2017745 in tuv rheinland. You need to demonstrate that your medical device meets the requirements in the medical devices directive mdd by carrying out a conformity assessment. The ivd regulation replaces the existing ivd directive.
Software suggesting diagnoses based on test results, i, iib or higher up to iii. Because of the many types of devices covered by the mdd, the specific requirements depend on the. Having regard tothe treatyestablishing the european. 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 written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of. Medical devices are products or equipment intended generally for a medical use. Oct 08, 2018 it will supersede the current medical device directive, 9342ec, following a threeyear transition period. Medical device according to european union medical devices directive. Medical device regulation ivd regulation ivdr medical device directive classification ce marking conformity.
Devices directive mdd 9342eec and the eu medical device regulation. Software for in vitro diagnostic medical devices in regulation eu 2017746. Apr 24, 2018 the new eu mdr, with a mandatory compliance date of 26 may 2020, replaces the former medical device directive mdd, and introduces new concepts, definitions, classification rules and procedural requirements for medical device software and particularly for software products currently regulated as class i medical devices in europe. Final version of the european medical device and ivd regulations published on 5 may 2017. Medical device ce marking service covering reusable medical devices, equipment, disposables, implants, drugdevice combination, and home healthcare devices across all classes spanning a diverse range of indications we have the experiences and expertise preparing technical documentation with any notified body of your choice. Recital 6 of directive 200747ec states that it is necessary to clarify. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe.
European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. 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 27 october 1998 on in vitro diagnostic medical devices. Eu medical devices directive mdd 9342eec and 200747ec. I3cglobal team of regulatory experts supports clients across the globe by streamlining the complex mdr ce certification process and by providing economic. He has an extensive knowledge of medical device management systems and medical device regulations worldwide iso 485. Directive 200070ec of the european parliament and of the council of 16 november 2000. Regulatory environment the variety of types and forms of medical devices results in difficult categorization for testing.
The medical device directives are new approach directives relating to the safety and performance of medical devices which were harmonized in the eu in the 1990s. Mahasweta pal, freelance medical writer on kolabtree, provides a comprehensive comparison of medical device regulatory compliance in the us fda vs that in europe eu mdr decomplicating the eu mdr has been a prime concern for medical device makers and, with higher vigilance and risks associated, medical device consultants have strategic roles to play. European medical devices directive 9342eec with 200747ec. Aug 29, 2017 the european parliament and council have approved a proposal to delay the full implementation of the medical device regulation 2017745 mdr for one year to 26 may 2021. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. Software as a medical device part ii in compliance magazine.
The eu commission is even considering revisiting this rule. Stand alone software is considered to be an active medical device. Read on to learn if eu mdr applies to your products, and what changes youll need to prepare for if you havent already. 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. 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. This is accomplished by rigorous and thorough software testing using prospectively approved software verification protocols. Typically they have preanalytical functions for ordering, sorting and distribution of test samples. Validation testing is needed to support what the users see and how they. Compliance required to export medical devices into the european union. The new regulations show a way forward towards the globalization of medical. Intertek medical notified body applied for mdr early 2018 to our swedish medical products agency mpa. Stricter rules for medical device software under the eu mdr. The eus in vitro diagnostics ivd regulation genewatch uk.
Carey school of business at arizona state university. 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. F2 labs can perform the emc and safety testing that is required by the medical device directive for. Further information on the revision of the medical device regulation can also be found on the eu website. The medical device regulation mdr 2017745 will replace the eu s current medical device directive 9342eec and the eu s directive on active implantable medical devices 90385eec.
The new regulation expanded the products in scope, as well as the list of regulated substances. The new european mdr and ivdr regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans. According to the in vitro medical devices directive, an ivd is defined as any medical device which is a reagent, reagent product, calibrator, instrument, equipment or system intended by the manufacturer to be used in vitro alone or in combination with other devices for the examination of samples derived from the human body including tissue. The updated version replaces an earlier version of meddev 2. European medical device directive essential requirements checklist page 8 of 22. Navigating the new eu rules for medical device software. F2 labs provides expert evaluation, testing, and where required notified body services for the following eu directives. Emc testing evaluates a product to determine if it is compatible with its intended electromagnetic environments. New eu mdr regulations and revamp of the medical device. It will supersede the current medical device directive, 9342ec, following a threeyear transition period. Medical devices directive 9342ec evaluation and testing. The european parliament and council have approved a proposal to delay the full implementation of the medical device regulation 2017745 mdr for one year to 26 may 2021. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. Directive 9879ec on in vitro diagnostic medical devices ivdmd will soon be 20.
From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. Mdr classification rule 11 for medical device software. Samd software as a medical device requirements for fda, eu. Directive 9879ec of the european parliament and of the council of 27 october 1998. Developers of digital standalone software must understand and follow the new mdr requirements before releasing them into the eu market if it falls under the definition of medical device. 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 directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has. To keep up with advances in science and technology, 2 new european regulations are replacing 3 existing directives in the years up to 2022.
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. How are medical devices regulated in the european union. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. The development of the iso 90003 standard as well as the european medical devices directive in 1993 helped bring some harmonization of existing laws with medical devices and their associated software, and the addition of iec 62304 in 2006 further cemented how medical device software should be developed and tested. Regulation ec no 7262004 of the european parliament and of the council.
New eu mdr regulations and revamp of the medical device directive. European legislation ensures the safety and efficacy of medical devices and facilitates patients access to devices in the european market. A subgroup of medical products, their market access, use, and market surveillance is regulated. Other standards or procedures applied by manufacturer. Formally known as council directive 9342eec of june 14, 1993, concerning medical devices. For the purposes of directive, the following definitions apply. Official journal of the european communities, volume 36, no. Software can be considered a medical device under eu law. Contrasted to pharmaceuticals or biologics, medical devices lack chemical action and do not depend on being metabolized.
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. In vitro diagnostic medical devices ivds are subject to the european directive 9879ec ivdd. The new eu mdr, with a mandatory compliance date of 26 may 2020, replaces the former medical device directive mdd, and introduces new concepts, definitions, classification rules and procedural requirements for medical device software and particularly for software products currently regulated as class i medical devices in europe. With about a year remaining until the new european medical device regulation takes effect to replace the current medical device directive 9342eec, its time to revisit what eu mdr means for medical device developers. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. Medical devices directive 9342 ec evaluation and testing.
The qualification of software, either as a device or an accessory, is independent of the softwares location or the type of interconnection between the software and a device. For a manufacturer to legally place a medical device on the european market the requirements of the relevant directive have to be met and a ce mark applied. Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. According to article 1 of council directive 9342eec, medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic andor therapeutic purposes and necessary for its proper. Are you prepared for changing medical device regulations. 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. Fda guidance on samd clinical evaluation in late 2017 fda issued a final guidance document on clinical evaluation for software as a medical device samd. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Medical device regulations and testing for toxicologic. According to european union medical devices directive mdd, medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic andor thera. On 15 july 2016, the european commission updated meddev 2. Our comprehensive medical device electromagnetic compatibility emc testing and certification services will help you to efficiently meet regulatory requirements and increase global market access. We have the experiences and expertise preparing technical documentation with any notified body of your choice. 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.
Medical devices shall have ce mark before being sold in the eu. Consolidated medical device directive 9342eec interactive web page. The eu directives on medical devices, active implantable medical devices and in vitro. Classification of software as a medical device bioslice blog. 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.
Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. 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 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. European medical device directive essential requirements. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Recital 6 of directive 2007 47ec states that it is necessary to clarify.
Oct 08, 2018 this is not specific to software but definitely includes software such as design inputs, verification testing, and validation testing. Since the 2007 amendment to the medical devices directive 9342ec1. Electromagnetic compatibility emc testing for medical. How to classify and ce mark software software in medical devices. Aug 05, 2016 on 15 july 2016, the european commission updated meddev 2. Council directive 9342eec of 14 june 1993 concerning medical devices. In practice, this means that all new devices, their manufacturers and other stakeholders in the field must meet the requirements of the mdr from may 26, 2020. Impact of eu medical device directive on medical device software. 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. Directive 200747ec of the european parliament amending medical device.
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