Active implantable medical devices directive aimdd 90385eec published in july 1990 2, the medical devices directive mdd 9342eec published in july 1993 1, and the in vitro diagnostic. Community rules applicable to all medical devices, this directive is. European medical device directive essential requirements. Reach and its impact on medical devices september 2008 in june 2007, the european unions regulation ec no. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. This seminar provides a detailed introduction to the european medical device legislation. She is now at stanford university studying for a phd. They will apply after three years as regards medical devices and after five years as regards in vitro diagnostic medical devices. The danish medicines agency would like to give guidance on the new regulations so that companies and the healthcare sector can prepare for 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. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Jan 27, 2015 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 liechtenstein.
Council directive 9342eec on medical devices mdd 1993. F2 labs can perform the emc and safety testing that is required by the medical device directive for. However, the general medical devices directive is of the greatest concern for two reasons. Devices directive 90385eec and the in vitro diagnostic medical devices directive 9879ec. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Medinfo medinfo council directive 9342eec on medical devices. These regulations contain the legislative measures necessary for the implementation of three european community directives. Date of application of the medical devices regulation postponed until may 2021. Download council directive 9342eec on medical devices mdd. The european commission has adopted and published the new eu regulations.
This directive covers medical devices systems that are connected to the va network and medical devices and systems that store sensitive patient information. All regulatory documents shown below were published by the european parliament or european commission. 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. This principally relates to class iii devices and associated conformity assessment procedures shall apply. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be. 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. Application to the devices referred to article 14a 44. One of the recent updates is the eu regulation 7222012 defining requirements for active implantable medical devices and medical devices manufactured utilizing tissues of animal origin, which became effective on august 29, 20 9. 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. 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 9342. Dr john clarkson is a university reader in engineering design and director of the cambridge engineering design centre. Directive 9368eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 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.
Application to devices referred to article 14a 41 annex v ec declaration of conformity production quality assurance 42 1. A medical device is any device intended to be used for medical purposes. Medical devices and the covid19 coronavirus pandemic learn more about devices such as diagnostic tests, ventilators, and personal protective equipment ppeincluding surgical masks, face. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards. However, the effects of the amendments to the mdd on competition in the u. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. With patient health and safety as a guiding principle, the council and the parliament adopted regulation 2020561 amending regulation eu 2017745 on medical devices regarding application dates of certain of its provisions on 23 april. Both the medical devices directive 9342eec and in vitro diagnostic medical device directive 9879ec require manufacturers or, their authorised representatives or others placing medical devices on the eea market, to provide certain information to the competent authorities in the eea member state where they have a registered place of. The objective of the health products regulatory authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in ireland and to participate in systems designed to do that throughout the european union. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products.
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. Hpra guide to classification of a medical device 4. Directive 200747ec of the european parliament amending medical device directive mdd provides medical device manufacturers with a compliance framework. The asean secretariat is based in jakarta, indonesia. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Council directive 9342eec concerning medical devices, as amended. Thus what differentiates a medical device from an everyday device is its intended use. 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. The association of southeast asian nations asean was established on 8 august 1967. 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. Medical devices internal market, industry, entrepreneurship. Council directive 9342eec of 14 june 1993 concerning medical devices. New european regulation for medical devices to replace 93. Vigilance contact points within the national competent authorities opens in a new window. The medical device directive is intended to harmonise the laws relating to medical devices. Regulatory guidance for medical devices check the legal requirements you need to meet before you can place a medical device on the market and see how mhra monitors compliance. 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. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. 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.
The first step to register medical devices in mexico is to determine the class of your device. This study examined the impact of this directive on the. 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. Registering medical devices in mexico market access. Mdd overview the mdd actually specifies three primary provisions for medical devices. Directive 2001104ec of the european parliament and of the council text with eea relevance of 7 december 2001. Invitro diagnostic devices directive 9879ec directive 9879ec on in vitro diagnostic medical devices interactive web page. Major changes include updating mandatory policy, responsibilities, definitions and inclusion of risk analysis and. He supervised the research work and has been closely involved with the. The medical device directive was published in 1993 by the european commission. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. Devices that are also machinery within the meaning of point a of the second paragraph of article 2 of directive 200642ec of the european parliament and of the council 1 shall, where a hazard relevant under that directive exists, also meet the essential health and safety requirements set out in annex i to that directive to the extent to. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.
Because of the many types of devices covered by the mdd, the specific requirements depend on the. 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. All medical devices sold within the european union must conform to this directive by june 1, 1998. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020. Pdf how are medical devices regulated in the european union. 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. Medical devices directive 9342ec evaluation and testing. Directive 200070ec of the european parliament and of the council of 16 november 2000. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the medical device. Medical device manufacturers were able to apply the medical device directive on january 1, 1995. Aug 19, 2014 while devices that are fda or health canadaapproved enjoy a faster response time and a streamlined registration procedure, devices that lack these approvals can still receive approval and registration in mexico.
Directive whereas certain medical devices are intended to administer medicinal products within the. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf, 7. Impact of eu medical device directive on medical device. There are eighteen rules outlined in annex ix of the directive and related regulation that lay down the basic principles of classification. If you need help determining the regulatory requirements for your medical device in europe, you may be interested in our custom regulatory strategy reports for europe.
B council directive 9342eec of 14 june 1993 concerning. Please help us maintain this list by reporting outdated or missing documents. Compliance with the revised directive became mandatory on 21 march 2010. Council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, as amended. The member states of the association are brunei darussalam, cambodia, indonesia, lao pdr, malaysia, myanmar, philippines, singapore, thailand and viet nam. However, a fundamental revision of those directives is needed to establish a robust. Cybersecurity for medical devices md project event 9 december 2014 erik vollebregt. Medical device directive 9342eec cemarking qnet, llc.
809 1145 1254 1251 762 1446 1571 421 507 90 1530 1020 961 1271 810 723 549 501 524 484 989 720 128 559 487 1487 967 1124 1435 700 1380 953 1219 191 279 539 991 1300 1307 855 1127 428 1008 1337 827 1396 611