Because of the many types of devices covered by the mdd, the specific requirements depend on. 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. Annex 9 directive 9342eec amended, concerning medical devices. Mdi consultants is an fda consulting company for the medical device, pharmaceutical and food industries on fda quality assurance, regulatory compliance and clinical issues for us and eu compliance.
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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. European medical device directive essential requirements. If you are unsure regarding classification, please come and talk with bsi. Learn more by using our medical device resource center as a global industry leader, we are committed to sharing best practice by providing easy access to information that helps our customers stay up to date on the latest changes to standards, current industry trends, as well as forwardlooking resources that can help you prepare for what lies.
Compliance with this directive is less than one year away and not an easy task to accomplish. Use features like bookmarks, note taking and highlighting while reading devine guidance for complying with the european medical device directive mdd. Evolution of med dev regulation national legislations 90385eec aimdd 9342eec. 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. Our white paper serves as a first step for medical device manufacturers in the eu market to better understand the immediate mdr implications by. References made to the medical device directives include the council directive. In its pages are detailed, tremendous changes to the current regulatory structures of the european market.
The mdd 9342eec kindle edition by devine, christopher. Impact of eu medical device directive on medical device software guy foe owono walden university. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace. Directive 200747ec of the european parliament amending medical device directive mdd provides. Medical device directive mdd 9342eec as modified by 200747ec. The directives are being amended by european legislators to better address patient safety concerns, hasten availability of products, foster. The new medical device regulation is complex and the changes it embodies are significant. Fill the form below to schedule the live webinar on demand session. If software is an accessory to a medical device, meddev 2. Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to hiv tests. Pdf the european medical device regulation 2017745eu. Building quality into medical device documentation and.
This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable directive, which helps to assure that medical devices are safe and effective for their intended use. Understanding the medical devices directive 9342eec 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. 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 new european medical device regulation and what it. Eu device regulations whats changing and what will be. 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. Normally intended for continuous use for more than 30 days. Devine guidance for complying with the european medical.
This seminar provides a detailed introduction to the european medical device legislation. If your organization manufactures and exports medical devices to the european union, you need to know about the ce mark and how the medical device directive will affect your organization. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. Analyzing the most influential changes and highlighting their implications for regulated medical device companies. Download mdr free mdr gap analysis mddmdr resources. 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 european commission has published an updated list of harmonized standards under the eus medical devices directive, in vitro diagnostics directive, and active implantable medical device directive. Compliance of medical devices with the new requirements. Impact of eu medical device directive on medical device.
New eu medical device regulations 2016live webinar register now. Active implantable devices and devices for in vitro diagnosis are covered. Compose in few minutes declaration of conformity compliant with applicable directives. That means, it must be a medical device as defined which is, at the same time, both active and implantable. 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. Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. Medical device technology brings together the fields of engineering and medicine to provide technical solutions to medical problems. Download council directive 9342eec on medical devices mdd. The european union is making major changes to the medical device directive which is its regulatory scheme for devices. The medical device regulation journal mdr 2017475 and 2017476 was published on the 5th of may 2017. M5 stand alone software is considered to be an active medical device. Council directive 9342eec of 14 june 1993 concerning medical devices. 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. 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.
In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices. Conformity with the medical devices directive is a mandatory requirement for ce marking your medical device to access to the european single market. On may 25, 2016, the various european union eu negotiators have finally reached a deal four years in the making on new rules for medical devices and. 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. Download from the link below the mdr in the main european languages. This live webinar course will provide guidance on the new requirement introduced with new eu medical device regulation. Download it once and read it on your kindle device, pc, phones or tablets. Click here to download a pdf version of the invitro diagnostic devices directive 98 79ec directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices introduction introduction article 1 scope, definitions article 2 placing on the market and putting into service article 3 essential requirements article 4 free movement. This interactive program is intended to help manufacturers and hospitals independently and in collaboration better understand steps they can take to improve medical device cybersecurity throughout the product life cycle. Questions relating to the implementation of directive 200747 ec 1. This webinar will help you understand the european union eu medical device directive mdd, which governs medical devices. Classification criteria definitions for the classification. B council directive 9342eec of 14 june 1993 concerning. Search for a standard by keyword or synonyms or filtering by directive s.
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. The medical device directive is intended to harmonise the laws relating to medical devices within the european union. Cyber intrusions through connected devices, operating systems, or software applications pose risks to patient safety and data privacy. Active implantable medical device a product falls within the field of application of the directive if it complies with the definition given in this directive. Gpc is cooperation partner of mit for cemdd certification for china. So if the duration definition change, most likely, you should completely reconsider your product and this can also put your company at risk.
Eu updates harmonized standards for medical device directives. 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. The previous ivd directive ivdd 9879ec which became mandatory in december 2003 provided regulatory requirements that facilitated free trade within the eu and eea. Medical device directive 2016 new eu medical device. Certification information download international certification trends. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Free movement, devices intended for special purposes. 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. Medical devices directive 9342ec evaluation and testing. Building quality into medical device documentation and impact of new device regulation context. Regulation of medical devices in europe the role of. Bsi training european medical devices directive requirements. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe.
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. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. 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. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om. New european regulation for medical devices to replace 93. B council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2.
The european unions medical device directive is one of the eus most frustrating and difficulttodecipher mandates. Devine guidance for complying with the european medical device directive mdd. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec. Medical device directive is not prescriptive on technical documentation format. F2 labs can perform the emc and safety testing that is required by the medical device directive for. Does the defined purpose fall under article 2a of the medical device directive. Advg00042 27 april 2009 this guide does not purport to be an interpretation of law andor regulations and is for guidance purposes only.
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