One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. Classification rules for medical devices other than. Whereas certain medical devices are intended to administer medicinal products within the meaning of 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. Comparing attributes of the asean medical device directive and. The 2008 regulations implement directive 200747ec of the european parliament and of the council oj no. Section 5 of this guide details what constitutes a custommade medical device. Guideline for designating authorities to define the. The amdd provides a more straightforward path to the market for medical device manufacturers. These regulations amend the medical devices regulations 2002 s.
This article has been published previously in the journal of medical device. Regulation of medical devices in europe the role of. Regional regulatory initiatives on medical devices. 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. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. Council directive 9342eec of 14 june 1993 concerning medical devices. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in article 1 of directive 6565eec and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking. Furthermore, through the chapter the legislation of the european union is presented, which includes directives of the new approach, with special reference to the medical devices directive, which. General medical devices are classified into four categories, ranging from low to high risk, depending on risk to the patient. Extends the definition of medical device to include products without a medical purpose that are similar to medical devices in characteristics and. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. 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. Since the latest version of the asean medical device directive the amdd was announced back 20, thailand and other asean member countries have adjusted their existing regulations andor.
Introductory guide to new medical device regulations. Asean agreement on medical device directive asean legal. 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. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. Council directive 90385eec 3 and council directive 9342eec 4 constitute the union regulatory framework for medical devices, other. New european regulation for medical devices to replace 93. Asean medical device directive implementation updates insight. Introduction to global medical device regulation and quality 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. The mdpwg is in the process of finalization a unified set of rules for mds, which would be called asean medical device directive amdd currently, out of the. While local laws of singapore, malaysia and indonesia have fully complied with the asean medical device directive amdd, it is encouraging. If the appliance is at the same time a medical device within the meaning of directive 9342eec 27 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. 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. As regards ar ticle 1684c tfeu, this regulation sets high standards of quality and safety for medical devices by. The rocky road to the new medical device regulation. Leanne etherington regulatory affairs manager, device technologies australia.
Eu medical device regulation february 2014 page 2 table of contents 1. 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. This seminar provides a detailed introduction to the european medical device legislation. Nsf health sciences medical devices amp technology centre, advanced manufacturing park, brunel way. Does the defined purpose fall under article 2a of the medical device directive. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purposes of. Cosmetic product dealers in singapore must comply with the cosmetic products regulation, which is in line with the asean cosmetic directive.
European medical device directive essential requirements. Building quality into medical device documentation and. Asean medical devices regulation infodent international. 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.
Medical device is regulated under indonesia moh decree 11902010. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. 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. Bsi training european medical devices directive requirements. Sources for mdr update commission proposal for a regulation of the european parliament and of the council on medical devices, and amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009. 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. Surg0007 guide for custommade medical device manufacturers. Medical devices directive 9342ec evaluation and testing. Council directive 9342eec concerning medical devices, as amended. Asean medical device directive implementation updates.
Grant bennett general manager, brandwood biomedical. By the spring of 2005, the european commission hopes to present the first draft of the revisions to the medical device directive to the european council and parliament. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. 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. Asean brings change to the medical device industry in thailand.
Current status of the asean medical device directive may 2019. The aimd 90385 eec also mentions the language requirement issue in article 4. 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. 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. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Several management standards are applicable to medical device manufacturing. These regulations contain the legislative measures necessary for the implementation of three european community directives. New european regulation for medical devices to replace 9342. With the help of drug safety network application, doctors can instantly report any suspected adverse drug reaction to food and drug administration, myanmar. The directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has.
While local laws of singapore, malaysia and indonesia have fully complied with the asean medical device directive, it is encouraging to see more developments of various member states in asean this year. F2 labs can perform the emc and safety testing that is required by the medical device directive for. For example, under the new directive, products that are classified as accessories could now be covered under the definition of a medical device. Neetal paranjape and matthew pitt therapeutic goods administration. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 5 of 22 manufacturer.
Guide to placing system and procedure packs on the market. Part 2 provides a summation of the mdds 12 annexes. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Compliance with this directive is less than one year away and not an easy task to accomplish. You need to demonstrate that your medical device meets the requirements in the medical devices directive. 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. Guideline for designating authorities to define the notification scope of a notified body conducting medical devices assessments 1 introduction nando 1, published and maintained by the european commission, is an electronic register that enables interested parties to consult regulatory information of notified bodies nbs. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices 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. 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. The association of southeast asian nations asean represents a group of 10. For a manufacturer to legally place a medical device on the european market the requirements of the relevant directive have to be met and a ce mark applied. Building quality into medical device documentation and impact. Directive 9879ec of the european parliament and of the council of 27 october 1998.
Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. These are organizations accredited by a member state to assess whether a medical device meets relevant regulatory requirements in the eu. The medical device directive mdd 9342eec, in effect since june 14, 1998, requires noneuropean medical device manufactures to acquire cemarking by complying with the medical device directive.
The en 60601 family of standards is of major importance for all electrical active devices for demonstrating compliance with the essential. 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. Aug 29, 2017 the introductory guide, designed as an interactive pdf. 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. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Some products will become regulated under medical device legislation for the first time. 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 new european medical device regulation mdr has been published in the official journal of the european union. Introductory guide to new medical device regulations launched. Directive 9342eec for medical devices mdd, amended by the directive 200747ec. 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. Hpra guide to placing system and procedure packs on the market surg00153 311 1 scope this document applies to system and procedure packs containing products that fall within the definition of a medical device under council directive 9342eec of 14 june 1993 concerning. The medical device directives are new approach directives relating to the safety and performance of medical devices which were harmonized in the eu in the 1990s.
Medical device directive 9342eec since the 14th june of 1998 each medical device must carry a ce mark. Asean standards healthcare isbn 9786020980317 general information on asean appears online at the asean website. Medical devices internal market, industry, entrepreneurship. An important element of the amdd is the asean common. This agreement, formally called the asean medical device directive amdd, provides a more. On this purpose, the medical device product working group mdpwg was created in january 2005 as one of the 12 working groups of the asean consultative committee for standards and quality accsq, to create a unied medical device regulation known as the asean medical device directive amdd, coordina. The most common medical device manufacturing standards include. Practical impact of new regulations due to the fallout from the early stages of the pip scandal, the european parliament issued, on june 11, 2010, a nonbinding call to the ec to create solutions to prevent recurrence of events such as those leading to the recall of pip implants in france. B council directive 9342eec of 14 june 1993 concerning.
Conformity assessment procedures provides the options available based on. In august 2014, the association of southeast asian nations asean signed a formal agreement that harmonized medical device regulations. From the report of the 8th asean medical device committee meeting and related activities industry training sessions and publicprivate forum which took place in the philippines in august. Medical devices manufacturers evidence and applications for artg inclusion session chair. Ce marking for european directives the language center. The main changes and features are that the regulation. In 2015, the association of southeast asian nations asean signed an agreement, formally called the asean medical device directive amdd, that aimed to harmonize medical device regulations. 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. Standalone software that falls under the mdd is always an active medical device according to art 2b of directive 90385 and annex ix, section 1. The active implantable medical device directive aimdd 90385 eec effective june 20, 1990 states that all active implantable medical device manufacturers must acquire cemarking to be able to put their products on the european market.
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