All devices being put on the market in the eu after rd june 1998 must bear ce marking. The number indicates the year of initial release 1993 and the consecutive number of directives in that year. Manufacturers have the duration of the transition period to update their technical documentation and. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. 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 device regulation journal mdr 2017475 and 2017476 was published on the 5th of may 2017. Some of these changes widened the alreadysubstantial gulf between the u.
Eu device regulations whats changing and what will be the impact. References made to the medical device directives include the council directive 9342eec concerning medical devices3 mdd, the council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices4 aimdd, and the directive 9879ec of the. In particular, article 8 aimd, article 10 mdd and article 11 ivdd outline the obligations of member states upon receipt of incident reports, from manufacturers or other sources, concerning any medical device which carries the ce marking. Competent authority under the terms of the medical device directive a competent authority is nominated by the government of each member state to monitor and ensure compliance with its provisions. This directive shall apply to active implantable medical devices. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. In the september issue of quality digest, part 1 of this article provided a general overview of the medical device directive and described the 23 articles that form the basis for the mdd. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 90385eec oj l 189, 20. If you are unsure regarding classification, please come and talk with bsi. How medical devices are regulated in europe eu commission transition guidance on directive 200747ec.
Software installed for the full functioning of a medical device is also included. 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. The new european medical device regulation and what it means. 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.
International regulation of medical device reprocessing. The medical device directive is intended to harmonise the laws relating to medical devices. 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. Any reports or decisions issued by the nb should be kept in the technical file.
Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. New european regulation for medical devices to replace 9342. Apr 16, 20 essential requirements can make or break ce certification in order to keep it, you need to follow the essential requirments outlined in the medical device directive. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Classification criteria definitions for the classification rules. According to the medical device directive, this single product is governed by the medicinal products directive, but, the relevant essential requirements of annex i to the medical device directive shall apply as far as the safety and performancerelated device features are concerned. In the framework of these authorizations, mtic intercertmay perform all activities assigned to notified body, necessary to check and issue the documentation in compliance with essential safety requirements of medical devices. Medical devices directive 9342eec european commission.
Medical device directive mdd including amendments, the latest being directive 200747ec, published as a consolidated text at. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Since the 14th june of 1998 each medical device must carry a ce mark. Pdf the european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal products on the market text with eea relevance. Evolution of med dev regulation national legislations 90385eec aimdd 9342eec. New european regulation for medical devices to replace 93.
Regulation of medical devices in europe the role of. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. How are medical devices regulated in the european union. This directive specifies that all medical devices must be provided with the ce. The active implantable medical devices directive with the official reference number 90385eec applies only to active implantable devices. Collectively known as the medical device directive mdd, this core legal framework consists of three directives that. However, a fundamental revision of those directives is needed to establish a robust.
Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 9342eec as regards medical devices incorporating stable derivates of human blood or human plasma. Respective to the risk class of the device, there are varying procedures that can be applied. Nbmed documents comprise of recommendations accepted by the european. In its pages are detailed, tremendous changes to the current regulatory structures of the european market. B council directive 9342eec of 14 june 1993 concerning. The manufacturer should first decide if the product concerned is a medical device as defined in directive 9342eec or an accessory to such a medical device, if it is not excluded from the scope of this directive and if it therefore comes within the scope of this directive. Medical device directive 9342 ewg mdd the mdd is the medical device directive or 9342eec. Eu medical device regulation february 2014 page 2 table of contents 1. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. F2 labs can perform the emc and safety testing that is required by the medical device directive for.
Pdf the european medical device regulation 2017745eu. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Part 2 provides a summation of the mdds 12 annexes. The directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has.
When determining the classification of medical devices under the eu directives, it is necessary to clearly understand a range of definitions related to medical devices as defined by the eu under the applicable device directives. Sep 12, 2017 in overvieweuropean medical device regulation. Advg00042 27 april 2009 this guide does not purport to be an interpretation of law andor regulations and is for guidance purposes only. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
Active implantable medical devices directive 90385eec. In particular, article 8 aimd, article 10 mdd and article 11 ivdd outline the obligations of member states upon receipt of incident reports, from manufacturers or other sources, concerning any. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. New european regulation for medical devices to replace 9342eec and 90385eec. Medical devices may only bear the ce marking if the essential requirements, which. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission.
Whereas council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 7 is the first case of application of the new approach to the field of medical devices. References made to the medical device directives include the council directive 9342eec concerning medical devices3 mdd, the council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices4 aimdd, and the. The manufacturer should first decide if the product concerned is a medical device as defined in the directive 9342 or an accessory to such a medical device and if it therefore comes within the scope of this directive. This document is meant purely as a documentation tool and the. Compliance with this directive is less than one year away and not an easy task to accomplish. These are organizations accredited by a member state to assess whether a medical device meets relevant regulatory requirements in the eu. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Medical device manufacturers were able to apply the medical device directive on january 1, 1995.
The new european medical device regulation and what it. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. A two day training course for personnel within medical device manufacturing industries who require a working knowledge of iso485 and the mdd. Council directive 9342eec of 14 june 1993 concerning medical devices.
This document is meant purely as a documentation tool and. M5 stand alone software is considered to be an active medical device. Part 2 provides a summation of the mdd s 12 annexes. If software is an accessory to a medical device, meddev 2. Ebm plays an everincreasing part in the evaluation of clinical trial data and results for highrisk class iib and class iii devices for compliance with annex x of the medical devices directive 9342eec. Classification criteria definitions for the classification. Bsi training european medical devices directive requirements. Medical devices internal market, industry, entrepreneurship. Extends the definition of medical device to include products without a medical purpose that are similar to medical devices in characteristics and. Essential requirements can make or break ce certification in order to keep it, you need to follow the essential requirments outlined in the medical device directive. Jun 15, 2016 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.
Essential requirements can make or break ce certification. The completed forms and contracts as well as any other documents submitted by. For a device to be classified as an active implant, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain. This page is about the meanings of the acronymabbreviationshorthand mdd in the medical field in general and in the hospitals terminology in particular. Active implantable devices and devices for in vitro diagnosis are covered. The european union is making major changes to the medical device. Pdf verification of manufactured products for the ivd directive nbmed. Building quality into medical device documentation and. 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. The medical devices directive states in annex x that as a general rule confirmation. Classification of medical devices european commission. Directive 9342eec for medical devices mdd, amended by the directive 200747ec. Devices directive 9342eec and the directive for active implantable medical. Does the defined purpose fall under article 2a of the medical device directive.
Prac cal implica ons for manufacturers peter rose, jens weirsoe, and mike wolf. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace. The main changes and features are that the regulation. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. The march 21, 2010, kickoff of the updated eu medical device directive confronted global devicemakers with quite a few changes in how their products are approved and sold in europe. International regulation of medical device reprocessing 2014. What links here related changes upload file special pages permanent link page. Medical devices guidance document classification of. These regulations contain the legislative measures necessary for the implementation of three european community directives. Ultrasounds diathermy device electrotherapy device iontophoresis device therapeutic laser intracerebral subcortical electroanalgesic stimulator spine electroanalgesic stimulator face stimulator muscle stimulator neurological stimulator neuromuscular stimulator bowel washout devices.
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