The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years. The medical device directive came into effect on 1st january, 1995. Medical devices directive 9342eec requirements for. 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. Directive 200070ec of the european parliament and of the council of 16 november 2000. General safety and performance requirements a comparison. The annex i essential requirements of the european medical device directives have been supercharged and reincarnated in the form of annex i safety and performance requirements in the new medical devices regulation eu mdr.
Medical device directive mdd 93 42 eec as modified by 200747ec. Understanding the medical devices directive 9342eec 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. Per the mdd directive 9342eec individual states can take unilateral action to withdraw medical devices from the market for safety concerns. Medical devices, medical information technology, medical software and. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark.
Essential requirements annex i, 9342eec as compliance. Essential requirements are part of the technical file or design dossier. 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. Whereas the essential requirements and other requirements set out in the annexes to this directive, including any reference to minimizing or. Instructions for use must accompany or be included in the packaging of one or more devices. The number indicates the year of initial release 1993 and the consecutive number of directives in that year.
Medical device directive 9342 ewg mdd the mdd is the medical device directive or 9342eec. Medentika gmbh manufactures custommade medical devices pursuant to customerordering partys specifications and guarantees accuracy of fit at implantsupported custommade devices as well as biocompatibility of materials. As a consequence all classes of medical devices will require clinical data as a part of the technical file, including class i. 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 by the manufacturer. Download declaration in word or pdf format, with your logo. New european regulation for medical devices to replace 93. Essential requirements annex i, 9342eec as amended by directive 200747ec. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Because of the many types of devices covered by the mdd, the specific requirements depend on. The relevant essential requirements of annex i to this directive shall apply as far as safety and performancerelated device features are. Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. The consolidated directive became mandatory on march 21, 2010.
The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. Hello, i have a question about the essential requirements checklist mdd 9342 eec. Understanding the medical devices directive 9342 eec 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 device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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.
Manufacturers have the duration of the transition period to update their technical documentation and. European medical device directive essential requirements. Medical devices directive 9342eec mdd and subsequent amendments. Essential requirements checklist medical device academy. European medical device directive essential requirements checklist pdf,160kb. Please find the latest consolidated mdd9342 eec below, with the biggest. For each standard updated in its en iso version, should i update the. Council directive 9342eec of 14 june 1993 concerning medical devices. This must be evidenced by the manufacturers risk analysis. 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. Mdd 9342eec medical device directive has been in place since june 14, 1998. If the appliance is at the same time a medical device within the meaning of directive 93 42 eec 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. General safety and performance requirements within the proposed the new mdr current essential requirements within mdd 9342eec 1. The medical device directive,published by the european commission from the.
There is a transition period of 3 years making the regulation fully applicable on may 26, 2020. European medical devices directive 9342eec with 200747ec. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereofhaving, regard tothe proposalfromthe commission. During this transitional period previous national regulations or the content of. Medical device directive mdd 9342eec as modified by 200747ec home medical device directive mdd 9342eec as modified by 200747ec this one hour webinar recording includes. Mdr medical devices regulation eu 2017745 mdi europa. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Right click on the link below to download to your computer select save target as mdd 9342 eec in pdf format status. 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. Details of the mdd 9342eec directive essential requirements. 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. Medical device directive 9342eec cemarking qnet, llc. Basic information about the european directive 9342eec. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22.
Medical device directive mdd 9342eec as modified by. Requirements for labelling, instructions for use and. Directive 9342eec on medical devices mdd the medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonize the laws relating to medical devices within the european union. This documentation demonstrates compliance with essential requirements annex i of the 9342eec. 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.
Medical device directive mdd gives the essential requirements that are applicable for instruments, apparatus, appliances, materials or other articles used by. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 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. Medical device directive mdd 9342eec as modified by 200747ec. European national states must translate this directive into national law. One of the important changes refers to essential requirement 14 from the mdd 9342eec annex i which will be deleted. For all classes of medical devices i, iia, iib, iii the manufacturer must have and keep uptodate a technical documentation, also called a technical file or a device master file. Right click on the link below to download to your computer select save target as. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. Right click on the link below to download to your computer select save target as mdd 93 42 eec in pdf format status.
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. B council directive 9342eec of 14 june 1993 concerning. Regulation eu 2017745 also known as the medical devices regulation mdr has been adopted on may 25, 2017 and will replace the medical devices directive 9342eec mdd and active implantable medical devices directive 90385eec aimdd. 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. Regulation ec no 12232009 and repealing council directives 90385eec and 9342eec text with eea relevance the european parliament and the council of the european union. Essential requirements medical devices directive applicable yn applied standards, procedures, justifi. The directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has. Checklist for exporters of medical devices from australia to the european community essential requirements annex i, 9342eec as amended by directive 200747ec. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to. Essential requirements checklist mdd 9342 eec background of annex x section 1. The essential requirements annex i which outlines the necessary precautions and requirements to be considered in the design, manufacturer, use and disposal of devices. Essential requirements annex i, 93 42 eec as compliance.
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