B council directive 9343eec of 14 june 1993 on the hygiene. Gpc is cooperation partner of mit for cemdd certification for china, usa and korea clients. The myo plus app from ottobock lets you easily configure the myo plus prosthesis control for the various myoelectric terminal devices. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs 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, in cooperation with the european parliament 1. Preventicus heartbeats is a clinically validated medical device that is in conformity with the essential requirements of medical device directive 93 42 eec eec or its respective national transpositions. Download cockpit ottobock and enjoy it on your iphone, ipad, and ipod touch. The current european union eu regulatory framework governing medical devices includes council directive 90385 eec on active implantable medical devices and council directive 93 42 eec on medical devices. Download mimi hearing test and enjoy it on your iphone, ipad, and ipod touch. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Regardless of the class a device belongs to, the manufacturer is obliged to prepare a technical file for the respective device or device family. Use the following index to navigate into the different sections of the directive. Active implantable medical devices directive 90385 eec. Accessory design guidelines for apple devices apple developer. Do not use after date mentioned caution, a specific warning or precaution associated with the device manufacturer.
Information on terumo medical devices and phthalates dehp, dbp, bbp phthalates of concerns and the medical device directive 93 42 eec last amended by directive 200747ec annex i, section 7. The classification rules of medical devices, as established in annex ix of directive 93 42 eec on medical devices, depend on the vulnerability of the human body, taking into account possible dangers inherent in the technical design and manufacture of the devices. Medical devices directive 93 42 eec try it for free on. Council directive 93 42 eec of 14 june 1993 concerning medical devices commission regulation eu no 7222012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90385 eec and 93 42 eec with respect to active implantable medical devices and medical devices. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. European union directives the eu is one of the largest publishers of online information in the world and the hunt for information can seem complex. B council directive 9342eec of 14 june 1993 concerning. Ce marking in medical devices, 9342at, 200747ec szutest. The procedures carried out by imq and the related assessment procedure are described in the imq regulation for the certification of medical devices ce marking directive 93 42 eec as amended available in the download section herein on the right directive 90385 eec as amended relating to active implantable medical devices. The new medical device regulation will enter into force after a threeyear transition period ending on may 25, 2020. Council directive 9338eec of 14 june 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors the council of the european communities, having regard to the treaty establishing the european economic community, and in particular the last sentence of articles 57 2, 66. Natural rubber latex, per requirements of eu directive ec 9342eec. 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. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint.
Further to this, the medical device directive 9342 eec is also applicable for accessories of medical devices. European medical device directive essential requirements checklist. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 93 42 eec concerning medical devices. The app also makes it possible to adapt the control to individual needs on an ongoing basis. 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. The revision of the medical devices directive 9342eec. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. Download socialdiabetes diabetes app and enjoy it on your iphone, ipad, and. If you define your product as a medical device, before you can market it in the eu, your product must meet the essential requirements in annex i of the medical devices directive mdd 93 42 eec. Medical devices directive 93 42 eec medical electrical equipment part 241. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. Directive 93 42 eec s on medical devices, annex v restricted to the aspects of manufacture concerned withsecuring gs.
For this purpose, the myo plus app connects to the myo plus tr prosthesi. European medical device directive essential requirements. Download socialdiabetes diabetes app and enjoy it on your iphone, ipad, and ipod touch. Medical devices are grouped into four product classes. Ce marking and european medical device directive 9342cee. Free iphone and android app for medical device qara. 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. Directive 9342eec, meet all maximum requirements for security and quality. This european standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff. Sg4n33r16 regulatory audit reports 90385 eec 2007 active implantable medical device directive leave a reply cancel reply your email address will not be published. New european regulation for medical devices to replace 9342. There are three medical device directives in place, the directive of active implantable medical devices 90385 eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. The changes concern, among others, the essential requirements which medical devices must satisfy in order to be. Directive 93 42 eec, meet all maximum requirements for security and quality.
Mednet as your authorized representative for medical devices acts as your legal entity towards the european authorities and fulfills on your behalf the obligations described in the medical device directive mdd 93 42 eec as well as additional services regarding the marketing of your medical devices within the european community. Surgical masks requirements and test methods purpose. 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. Council directive 9343eec on the hygiene of foodstuffs. 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. Contents of technical documentation for mdd 9342eec and. Understanding the medical devices directive 9342 eec directive 93 42 eec 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. The media library feature allows accessories to download the. Medical devices directive 93 42 eec last official journal reference wednesday 25th of march 2020 description. Provisions of directive 200747ec directive 200747ec amends directive 90385 eec on active implantable medical devices and directive 93 42 eec on medical devices. This document is available in either paper or pdf format. Download the most important ce product guidelines here. Particular requirements for basic safety and essential performance of surgical luminaire. Council directive 93 42 eec of 14 june 1993 concerning medical devices.
Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Emergo groups iphone app contains reference information for regulatory and quality assurance professionals. Council directive 9338eec of 14 june 1993 coordinating the. Classification, indicating the rule bullet point according to annex ix of directive 93 42 eec statement as to whether the ingredients of the product include a substance as defined in annex i section 7. Direttiva 93 42 cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici. For the purposes of this directive, central nervous system means brain, meninges and spinal cord. Document viewer the document doesnt have a viewable format at this time. Directive 2006116ec of the european parliament and of the council of 12 december 2006 on the term of protection of and certain related rights codified version is the consolidated version of 93 98ec with amendments that is in force since 2007. Directive 93 68 eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. As a consequence of this clause a given product is either covered by directive 89686 eec or by directive 93 42 eec. Summary list of harmonised standards under directive 93 42 eec for medical devices 17. Medical devices directive 93 42 eec pdf download 10yi83. Download notice follow this document table of contents hide table of contents.
Application of the classification rules shall be governed by the intended purpose of the devices. Council directive 93 42 eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document. 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 ce marking directive 9368eec ce marking association. Council directive 93 15 eec of 5 april 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses. Medical devices directive mdd 9342eec with 200747ec consolidated version. The medical device directive council directive 93 42 eec 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. Directive 9342eec as amended concerning medical devices. The quality management system in place at preventicus gmbh is certified according to iso 485. Download council directive 9342eec on medical devices mdd. Council directive 9316eec of 5 april 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications official journal l 165, 07071993 p. Annex ii section 3 the manufacturer must inform the notified body of any plan for substantial changes to the quality system or the productrange covered. 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.
Ce marking and european medical device directive 93 42 cee. Council directive 93 98 eec of 29 october 1993 harmonising the term of protection of and certain related rights is a european union directive in the field of eu law, made under the internal market provisions of the treaty of rome. Directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to. Dexdor dosing calculator allows healthcare professionals to calculate easily the infusion rate of dexdor. Council directive 9342eec of 14 june 1993 concerning medical devices. New european regulation for medical devices to replace 93. Council directive 9342eec of 14 june 1993 concerning. If followed by a number notified body it is a type approved device compliant to medical device directive 93 42 eec 200747ec or in vitro diagnostic medical device 9879ec useby date. Bsi training european medical devices directive requirements. 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. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device.
In vitro diagnostic medical devices are governed by directive 9879ec. Download fibricheck and enjoy it on your iphone, ipad and ipod touch. Ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives. Directive 9342eec mdd medical devices directive with. The medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of. For devices falling under directive 93 42 eec 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 93 42 eec. F1 substituted by directive 200747ec of the european parliament and of the council of 5 september 2007 amending council directive 90385 eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 93 42 eec concerning medical devices and directive 988ec concerning the placing.
Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. The mimi hearing test is a medical device according to directive 9342eec. Nol 1692 official journalofthe europeancommunities. 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.
Read here more about the medical devices directive 9342eec mdd, which was taken effect in 1993, revised in 2010 and will be replaced by the mdr in. Commission directive 963euratom, ecsc, ec granting a derogation from certain provisions of council directive 9343eec on the hygiene of foodstuffs as regards the. 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. 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. Council directive 93eec of 5 april 1993 on unfair terms. Download declaration in word or pdf format, with your logo. Every day a huge range of information goes online, including legislation, statistics, press releases, policy reports and more. 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. If the device is intended to be used in combination with another device, the. The proposal is the result of long discussions between the commission and stakeholders in the 27 member states and aims to address the perceived weaknesses of the previous regime. Directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating stable derivates of. Download alert for embrace watch and enjoy it on your iphone, ipad, and. Medical devices internal market, industry, entrepreneurship.
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