There were several updates to the meddevs released as supporting documents for the m5 version of the mdd 93 42 eec as modified by 200747ec. How to qualify, classify and ce mark software software in medical. Council directive 9342eec of 14 june 1993 concerning medical devices direttiva 9342cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici oj l 169, 12. Medical device directive 93 42 ewg mdd the mdd is the medical device directive or 93 42 eec.
Products within the scope of mdd article 1 of the directive defines a medical device to mean 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. M5 mdd archives medical device academy medical device academy. Definitions definitions for the classification rules. Harmonized standards for medical software vde medical devices. For that purpose, your product needs to go through the ce marking process. Recital 6 of directive 200747ec states that it is necessary to clarify that software in its own right, when specifically. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of. Classification criteria definitions for the classification rules. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to. Duration transient normally intended for continuous use for less than 60 minutes.
In that case, of importance are the medical device directives mdd. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Depending on the medical devices directive 93 42 eec mdd the member states of the european economic area, eea, can require their own language. As the market transitions from the medical devices directive mdd 9342eec and the active implantable medical device aimdd 90385eec to the medical device regulation mdr no. A medical device is defined in directive 9342eec as. Medical device directive 93 42 eec mdd annex ix classification criteria medical devices directive explained how medical devices are regulated in europe i. Full text of the european medical devices directive 93 42 eec including amendments by 200747ec. Mdd annex ix classification criteriapresentationeze. New eu mdr regulations and revamp of the medical device directive. Eu medical devices directive mdd 93 42 eec and 200747ec. In the context of medical devices directive 9342ec mdd and this guidance, standalone software means software which is not. Medical device directive 9342ewg mdd the mdd is the medical device directive or 9342eec.
Medical devices directive 93 42 eec try it for free on. Dec 15, 2015 the european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease. Software installed for the full functioning of a medical device is also included. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.
The european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease falling under the medical device directive mdd. Medical device directive 93 42 eec the medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. Please find the latest consolidated ivdd 98 79 ec below. Eu medical devices directive mdd 9342eec and 200747ec. For ce marking of medical devices and software, contact certification company. Mdr compliance deadline extension official for some. Bsis european medical devices directive requirements course is designed to provide a top level overview of the guidelines of the european medical device directives mdd 9342eec and comprehensive information on the mdd 200747 changes. Eu medical device directive 9342eec labelling requirements. Classification criteria definitions for the classification. Then there were two more meddevs released in december, 2010 related to clinical study requirements in europe. Mandatory language requirements for medical devicesupdatejan.
The 200747ec amendment was established on september 5, 2007 and the consolidated directive became mandatory on march 21, 2010. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the medical device. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in article 1 2 a, as specified by the manufacturer. The essential requirements of the medical device directive 93 42 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. Software as a medical device part ii in compliance magazine. Questionnaires and application forms for medical devices. They can be used not only as applications but also as guidelines and checklists, helping you through the complex process of application for, say, a conformity assessment procedure in accordance with directive 9342eec mdd. I used the references below to create this article. If software is an accessory to a medical device, meddev 2. Vde medical devices and software harmonized standards for medical.
Medical device under meaning of the directive 9342eec 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 application, intended by the manufacturer to be used for. Interactive web page allows for inpage navigation from section to section. Ce certification class iia medical device ce marking. The medical device directive 9342eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. Reporting changes to your notified body vicky medley head of qms, medical devices.
For devices falling under directive 93 42 eec other than custommade devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules see articles 9 and 11 of directive 93 42 eec. European medical device directive essential requirements. Read here more about the medical devices directive 9342eec mdd, which was taken effect in 1993, revised in 2010 and will be replaced by the mdr in. Essential requirements checklist mdd 9342 eec misc. Mdd the medical devices directive product assurance by dnv. Classification of medical devices european commission. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. For products classified with medium to high degree of risk class is, im, iia, iib and iii the medical device directive requires a conformity assessment procedure involving a notified body.
If you are unsure regarding classification, please come and talk with bsi. Depending on the medical devices directive 9342eec mdd the member states of the european economic area, eea, can require their own language. Council directive 9342eec of 14 june 1993 concerning medical devices mdd, council directive 90385eec of 20. Classification of medical devices and their routes to ce.
Due to its complexity, classification of standalone software will be covered in. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. Directive 9342eec, as amended, allows for derogation from the classification rules outlined in its annex ix in light of technical progress or on information gathered from postmarket experience with the device. The number indicates the year of initial release 1993 and the consecutive number of directives in that year.
A manufacturer who wishes to sell medical devices on the eu market must meet the regulations of the medical device directive 9342eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Because of the many types of devices covered by the mdd, the specific requirements depend on the. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Mdd 9342eec active implantable medical devices aimd 90385eec.
Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. To prove that your device complies with the essential requirements of these ce directives, you need to affix a ce mark to it. Directive 200747ec2 which further amends directive 9342eec and became applicable as from. 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. Pining a definition to the term medical device has never been easier since the introduction of medical device directive 9342eec. Please find the latest consolidated ivdd 9879ec below. Software, accessories, conformity assessment, combination of medical devices a rationale and history sheet is available. Classification of medical devices and their routes to ce marking. The amendment is necessary due to continual advancements in technology and development of. The directive 93 42 eec applies for the placing on the market and launching of medical devices and their accessories. Medical devices guidance document classification of.
The medical devices directive 93 42 eec the medical devices directive applies to medical devices, accessories and medical software. Medical device is defined as instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of desiases, injuries or disabilities. The classification of medical devices in the european union is outlined in annex ix of the council directive 9342eec. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Stand alone software is considered to be an active medical. The amendment is necessary due to continual advancements in technology and development of international initiatives. Eumdr article 61 4 in the case of implantable devices and class iii devices, clinical investigations shall be performed, except if. Medical devices directive 93 42 eec pdf download 10yi83. Software, which drives a device or influences the use of a device, falls automatically in the same class.
Canada essential requirements checklist for mdd 9342eec. Aug, 2019 thank you for your question about clinical evidence and investigation requirements with regard to clinical investigations of higher risk devices. Article 1 of the directive defines a medical device to mean 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. European medical device directive essential requirements checklist page 1 of 22. A medical device is defined in directive 93 42 eec as. As a notified body under the medical devices directives, we have one of the broadest.
Md 1111 software md 1106 active dental devices md 1108 active rehabilitation devices and active creation date. 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. This free of charge application was designed to help manufacturers, consultants, notified. Medical devices internal market, industry, entrepreneurship. Details of the mdd 9342eec directive essential requirements. 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. Introduced on june 14, 1998, and amended on september 5, 2007, the directive came into effect in march 2010 and established the essential requirements and harmonized standards for the manufacture, design, and. European national states must translate this directive into national law. Medical device directives means the 3 following directives.
Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Thank you for your question about clinical evidence and investigation requirements with regard to clinical investigations of higher risk devices. Directive 200070ec of the european parliament and of the council of 16 november 2000. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Home ce certification ce marking medical devices mdd 9342eec. The ivd directive was amended and corrected over time. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Classification of md acc mdd 9342eec annex ix product. Article 1 of the directive defines a medical device to mean 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. June 2011 in vitro diagnostic medical device directive 98 79 ec the ivd directive was published in 1998 by the european comission.
Mandatory language requirements for medical devices. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Bsi training european medical devices directive requirements. Medical devices directive 9342eec pdf download 10yi83. Council directive 9342eec of 14 june 1993 concerning medical devices. The medical devices directive applies to medical devices, accessories and medical software medical device is defined as instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of desiases, injuries or. Medical devices technologies active medical devices bsi. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.
This change means that devices not custom made devices that are selfcertified class i under the current medical devices directive 9342eec mdd but that will be upclassified under the mdr will not have to be certified to the new regulation from the date of application may 26 th, 2020. Due to definition changes on medical device in mdr, please be aware that even though the decision diagram to assist qualification of samd from meddev 2. Details of the mdd 93 42 eec directive essential requirements. New european regulation for medical devices to replace 93. Devices directive 9342eec mdd or the directive 90385eec on. Directive 93 42 eec 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. Quality assurance and business systems related topics. Iec 60601 medical electrical equipment safety standards series. Medical devices directive 9342eec mdd and subsequent amendments. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12.
Specifically, there were four in december, 2009 and one in june, 2010. All of them have written the mandatory use of their own language for the information on the product andor labelling depending on mdd annex i, paragraph into their national law transposing the mdd. The references published under directive 93 42 eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below. Aug 26, 2019 as the market transitions from the medical devices directive mdd 93 42 eec and the active implantable medical device aimdd 90385 eec to the medical device regulation mdr no.