Medical device directive 9342eec since the 14th june of 1998 each medical device must carry a ce mark. Medical device directive 2016 new eu medical device. The medical device directive,published by the european commission from the european regulatory affairs company, mdss. In order to comply with the european union eu medical device directives 90385eec active implantable medical directives aimd, 9342eec medical device directive mdd and 9879ec in vitro diagnostics device directive ivdd referred to as the directives hereafter, manufacturers must conduct postmarket surveillance pms. Pdf the european medical device regulation 2017745eu. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission.
Medical device single audit program mdsap the mdsap program is reaching the end of its pilot phase at the end of december 2016 and enters its implementation phase. Overview of eu medical device regulations and guidances that impact medical device complaint handling. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. New european regulation for medical devices to replace 93. 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. Iso 485 is designed to be used by organizations involved in the design, production, installation and servicing of medical. Council directive 6565eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products 4. Medical devices guidance document classification of. Final version of the european medical device and ivd regulations published on 5 may 2017. The mdr will replace the current eus medical device directive 9342 eec and the eus directive on active implantable medical devices 90385eec. Directive 200070ec of the european parliament and of the council of 16 november 2000.
Medical device files were not mandated in the previous revision of the standard, iso 485. Medical devices and personal protective equipment ppe bsi. In june 2015, a new draft of both the medical device regulation and the in vitro diagnostic regulation was published and a final publication is since then expected to be released in may 2017. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. New eu medical device regulations 2016live webinar register now. With the help of drug safety network application, doctors can instantly report any suspected adverse drug reaction to food and drug administration, myanmar. My objective is to share my knowledge and experience with the community of people working in the medical. Quality management system qms all processes that are part of a manufacturers qms will now need to be developed using a riskbased approach. Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of. Blue guide on the implementation of eu product rules, en, c 27201, 072016. As regards ar ticle 1684c tfeu, this regulation sets high.
F2 labs can perform the emc and safety testing that is required by the medical device directive for. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. 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 devices regulation what you need to know bsi. Navigating the new european union medical device regulations. Medical device regulations journal of young pharmacists. This live webinar course will provide guidance on the new requirement introduced with new eu medical device regulation. Medical devices could not be marked under the ppe directive. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the.
On 25 may 2016 during trilogue between eu councile, parliament and commission, political. Medical devices directive testing mdd 9342eec f2 labs. In laymans terms, this means that any medical device md or invito diagnostic ivd that doesnt comply with the new iso485. How the eu medical device regulation changes ce marking. Healthcare conference 2016 the new eu medical device regulations. On 15 july 2016, the european commission updated meddev 2. The medical device regulation mdr has entered into force on may 26th 2017. Previously in many countries medical device regulations rarely existed and there were.
Journal of young pharmacists, vol 8, issue 1, janmar, 2016. Home medical device regulation and iso quality standard. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. However, with the current state of these regulatory changes set to take place, once fully implemented, the medical device regulations will greatly aid medical device professionals, patients, and regulatory bodies toward safer and more effective products. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of. Consolidated medical device directive 9342eec interactive web page. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. Final version of the european medical device and ivd regulations. It is under the dutch presidency of the council and representatives of the european parliament that a political agreement was reached on the content of the. Iso 485 is the internationally recognized quality management systems standard for the medical device industry. The term medical device, as defined in the food and drugs act, is any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in. Ster ilization of medical devices requirements for medical devices to be designated sterile par t 2. Directive 90385eec on active implantable medical devices directive 9342eec on medical devices proposal for a regulation on medical devices.
Fill the form below to schedule the live webinar on demand session. Food and drug administration, myanmar drug safety network is an adr reporting application for both android and ios users, conceived by food and drug administration, myanmar. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. 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 new european union medical devices regulation deloitte. Medical devices relied on being deemed a barrier to infection in the medical devices directive mdd in order to gain a ce mark. Complying with the new regulation presents a whole new set of challenges for raqa professionals, and it is key to understand those changes and develop a sound transition strategy. 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. Directive whereas certainmedicaldevices are intended to administermedicinal products withinthemeaning of. Blog page 3 of 4 medical device regulation and iso. Medical devices directive 9342ec evaluation and testing.
Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. Summary of the 2016 changes in medical devices regulation. The asean secretariat is based in jakarta, indonesia. Regulationsrequirementsineuropeusajordansaudiarabia. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. 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. South africa medical devices regulatory systems at country. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. The new eu medical device regulation mdr 2017745 represents a seismic change in how medical devices are regulated in the eu. Medical device directives means the 3 following directives. The main changes and features are that the regulation.
The ppe directive along with some other directives wasspecifically excluded. Revision of mdd, 9342eec has the final revision been published. The updated version replaces an earlier version of meddev 2. How the new eu medical device regulation will disrupt and.
Medical device directive 2016 new eu medical device regulations emdr 2016 live webinar. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. Learn how to choose your notified body or how the device regulation is different in other countries. Easy medical device is a platform for tools and resources for regulatory affairs, quality management, regualtory compliance.
Download the medical certifications leaflet here in pdf format. 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. Medical device regulation in the eu is based on the new. How to produce a technical fle ec marking guidance needed mdd 9342eec directive. Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020. Monir founded easy medical device to help medical device companies to place compliant products on the market.1263 893 564 1462 1267 122 1183 329 1477 573 1276 1070 1046 740 628 930 940 1134 644 1103 1042 384 332 1248 524 107 1121 1518 1484 308 804 377 613 1284 1070 1238 817 556 936 212