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. Classification criteria definitions for the classification. Medical device directive 2016 new eu medical device. Analyzing the most influential changes and highlighting their implications for regulated medical device companies. 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. 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. Devine guidance for complying with the european medical device directive mdd. Impact of eu medical device directive on medical device software guy foe owono walden university.
It will explain the regulation and which products are covered, the involvement of notified bodies, how to choose one and outline what a manufacturer must do. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. 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. Eu device regulations whats changing and what will be. New european regulation for medical devices to replace 93. This seminar provides a detailed introduction to the european medical device legislation. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Download mdr free mdr gap analysis mddmdr resources. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace. 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. This dissertation is brought to you for free and open access by the walden dissertations and doctoral studies collection at scholarworks.
Regulation of medical devices in europe the role of. 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. 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 device regulation journal mdr 2017475 and 2017476 was published on the 5th of may 2017. The european union is making major changes to the medical device directive which is its regulatory scheme for devices. Free movement, devices intended for special purposes. You need to demonstrate that your medical device meets the requirements in the medical devices directive. Medical device directive mdd 9342eec as modified by 200747ec. M5 stand alone software is considered to be an active medical device.
Conformity with the medical devices directive is a mandatory requirement for ce marking your medical device to access to the european single market. New eu medical device regulations 2016live webinar register now. 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. 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. 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. Medical device directive is not prescriptive on technical documentation format.
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. 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. 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. Impact of eu medical device directive on medical device. The new medical device regulation is complex and the changes it embodies are significant.
Active implantable devices and devices for in vitro diagnosis are covered. Mdd the medical devices directive product assurance by. Cyber intrusions through connected devices, operating systems, or software applications pose risks to patient safety and data privacy. Questions relating to the implementation of directive 200747 ec 1. Compliance of medical devices with the new requirements.
The medical device directive is intended to harmonise the laws relating to medical devices within the european union. Search for a standard by keyword or synonyms or filtering by directive s. Compose in few minutes declaration of conformity compliant with applicable directives. 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. That means, it must be a medical device as defined which is, at the same time, both active and implantable. 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. Ivds are medical devices instruments, reagents and systems used to determine medical information for the diagnosis of a disease or condition. Download from the link below the mdr in the main european languages. 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. If you are unsure regarding classification, please come and talk with bsi. 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. 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.
Directive 200747ec of the european parliament amending medical device directive mdd provides. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Building quality into medical device documentation and. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. In its pages are detailed, tremendous changes to the current regulatory structures of the european market. Medical devices directive 9342ec evaluation and testing. The european unions medical device directive is one of the eus most frustrating and difficulttodecipher mandates. Use features like bookmarks, note taking and highlighting while reading devine guidance for complying with the european medical device directive mdd.
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. Medical device technology brings together the fields of engineering and medicine to provide technical solutions to medical problems. Compliance with this directive is less than one year away and not an easy task to accomplish. Evolution of med dev regulation national legislations 90385eec aimdd 9342eec. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. 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. Software installed for the full functioning of a medical device is also included. References made to the medical device directives include the council directive.
Bsi training european medical devices directive requirements. Medical devices directive 9342eec pdf download, private parts howard stern epub download ae94280627 om. 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. European medical device directive essential requirements.
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. 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. 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.
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. 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. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. Annex 9 directive 9342eec amended, concerning medical devices. The mdd 9342eec kindle edition by devine, christopher. Normally intended for continuous use for more than 30 days. 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. Gpc is cooperation partner of mit for cemdd certification for china. Download it once and read it on your kindle device, pc, phones or tablets.
Certification information download international certification trends. So if the duration definition change, most likely, you should completely reconsider your product and this can also put your company at risk. The previous ivd directive ivdd 9879ec which became mandatory in december 2003 provided regulatory requirements that facilitated free trade within the eu and eea. The directives are being amended by european legislators to better address patient safety concerns, hasten availability of products, foster. 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. Download council directive 9342eec on medical devices mdd. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Pdf the european medical device regulation 2017745eu. Council directive 9342eec of 14 june 1993 concerning medical devices. B council directive 9342eec of 14 june 1993 concerning.
This live webinar course will provide guidance on the new requirement introduced with new eu medical device regulation. 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. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec. Fill the form below to schedule the live webinar on demand session. 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. Devine guidance for complying with the european medical. Building quality into medical device documentation and impact of new device regulation context.
If software is an accessory to a medical device, meddev 2. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. This webinar will help you understand the european union eu medical device directive mdd, which governs medical devices. The new european medical device regulation and what it.
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