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. How are medical devices regulated in the european union. Other standards or procedures applied by manufacturer. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 9342eec annex ix. Further to this, the medical device directive 9342eec is also applicable for accessories of medical devices. Classification criteria definitions for the classification. 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. For devices falling under directive 9342eec other than custommade devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules see articles 9 and 11 of directive 9342eec.
Please click on the chart to get an enlarged view in the case of medical devices with a low risk class i, like crutches, the manufactuerer or his european representative under his own responsibility may guarantee and declare that the devices meet the requirements of the directive. If a person becomes incapacitated, they may not be able to make medical decisions at that moment. European medical device directive essential requirements. These are, for example, additional equipment or singleuse devices. Council directive 9342eec of 14 june 1993 concerning medical devices. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. 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.
Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Formally known as council directive 9342eec of june 14, 1993, concerning medical devices. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. The technical documentation must be kept in the premises of the manufacturer or the authorized representative in a clear, organized, readily searchable and unambiguous manner and shall include the elements presented in this document. Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020 date of application to meet the requirements of the mdr. Mexicos medical device registration regulations may seem complex, and they are mostly only published in spanish. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of article 1 of directive 200183ec 1, that device shall be. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. The member states of the association are brunei darussalam, cambodia, indonesia, lao pdr, malaysia, myanmar, philippines, singapore, thailand and viet nam. Accessories and other parts for active implantable medical. With an experienced team in tokyo, emergo can assist your company with the medical device registration process in japan. Eu updates harmonized standards for medical device directives.
This guidance document elaborates upon the definition of significant change in the regulations, in order to assist manufacturers in determining whether a change proposed to a class iii or iv medical device requires the submission to health canada of a licence amendment application, prior to introducing the device to the market. Directive whereas certain medical devices are intended to administer medicinal products within the. Withdrawn regulating medical devices in the event of a. However, a fundamental revision of those directives is needed to establish a robust. Emergo can prepare all necessary documentation for premarket submission, certification, and. It was released in may 2017 and will replace both, the mdd and the directive for active implantable medical devices aimd. For more than 25 year it served as the most important regulatory document in europe. The ce marking also means that the product can be freely marketed anywhere in the eu 27 member states of the eu and efta countries, iceland, norway and. 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.
F2 labs can perform the emc and safety testing that is required by the medical device directive for. Registering medical devices in mexico market access. Compliance required to export medical devices into the european union. Medical devices directive 9342ec evaluation and testing. Unlike the directives, the regulations will apply directly to member states without.
Official journal of the european communities, volume 36, no. Technical documentation for medical devices guidance for submission. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Medicines and related substances amendment act 59 of 2002. The new european medical device regulation mdr has been published in the official journal of the european union. South african medicines and medical devices regulatory. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. New european regulation for medical devices to replace 93. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. The mdr and ivdr represent a significant development and strengthening of the existing regulatory system for medical devices in europe and will replace the original directives which have been in place for over 25 years. Council directive 6565eec of 26 january 1965 on the.
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. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. Hpra guide to classification of a medical device if the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. Medical device directive mdd9342eec the medical device directive was published in 1993 by the european commission. 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. The association of southeast asian nations asean was established on 8 august 1967. Directive 200312ec on the reclassification of breast implants and the, directive 200550ec on of hip, knee and shoulder joint replacements, to achieve conformity the eu publishes guidance documents including meddevs and the harmonized standards such as en iso norms which define methods and both product 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. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. Medical device directive 9342eec latest amended by directive 200747ec terumo product related risk management documents en 15986. See advance directive, durable power of attorney, living will. Medical directive definition of medical directive by.
Guidance for the interpretation of significant change of a. Directive 90385eec, and other medical devices, covered by directive 9342eec, were regulated in two separate legal instruments. Medical device technology brings together the fields of engineering and medicine to provide technical solutions to medical problems. Ongoing coordination with dhsicscert, medical device manufacturers and security researchers on reported medical device vulnerabilities 2015 fostered collaboration with multiple stakeholder groups across the ecosystem issued productspecific safety communications on medical device vulnerabilities 2016 draft postmarket cybersecurity guidance. This document is meant purely as a documentation tool and. 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 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. This proposal is expected to follow a similar path toward adoption and implementation, but probably with less discussion and controversy. 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. Final version of the european medical device and ivd regulations published on 5 may 2017. At that time, the manufacturers had the choice to apply either national regulation or the medical device directive. Directive 9879ec of the european parliament and of the council of 27 october 1998.
Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. The mdr entered into force on 25 may 2017, marking the start of the transition period for manufacturers selling medical devices into europe. 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. Accessories and other parts for active implantable medical devices page 37 vdtuevdocument dn. Accessories are classified in their own right separately from the device with which they are used. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of.
The medical device directive was introduced in 1993 and appended in 2007 by 200747ec. A medical directive is a legal document that contains instructions regarding a persons health care decisions if they should become incapacitated. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. The legislation now being in the form of a regulation, rather than a directive, means that the eu law is directly applicable. Directive 200070ec of the european parliament and of the council of 16 november 2000. Medical devices directive 9342eec pdf download 10yi83.
Pmda medical device registration and approval in japan. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Mexico is the largest medical device importer in latin america and is a key market for medical device manufacturers not only in north america but also around the world. The asean secretariat is based in jakarta, indonesia. Medical device directive 9342eec cemarking qnet, llc. Class i medical devices conformity assessment medcert. Part 2 provides a summation of the mdds 12 annexes.
Summaries of information about the most serious medical device recalls. References made to the medical device directives include the council. Therefore, medical directive helps prepare the person for such. B council directive 9342eec of 14 june 1993 concerning. According to a report from emergo, the first 50 pages of the new list which also covers nonmedical device industry products refers to both new and supersededamended standards under the eus medical devices directive, in vitro diagnostics directive, and active implantable medical device directive. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. European medical device directive essential requirements checklist page 8 of 22.
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