2007 47 ec medical device directive pdf

Medical device directive 9342eec latest amended by directive 200747 ec terumo product related risk management documents en 15986. Directive 200747 ec introduced a new paragraph in the articles 3 of directive 90385eec and directive 9342eec, respectively, which states that where a medical device is also machinery, it shall meet the essential health and safety requirements ehsr of the machinery directive to the extent to which they are more specific than the essential. Since directive 200747 ec is addressed to the member states, preliminary transposition into national law is indispensable for the application of the corresponding provision by the various economic operators. The european commission guidance indicates that on 21 march 2010 medical devices placed on the market at that time must comply with directive 2007 47 ec. Classification criteria definitions for the classification. The directive 200747 ec does not define any transitional period. Do not use after date mentioned caution, a specific warning or precaution associated with the device manufacturer.

Mdd richtlinie 9342ewg medizinprodukterichtlinie deutsch. Directive 200747ec guidance document for mdd 9342eec. Directive 200747 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988 ec concerning the placing of biocidal products on the market text with eea relevance. Directive 200747 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical. If followed by a number notified body it is a type approved device compliant to medical device directive 9342eec 200747 ec or in vitro diagnostic medical device 9879 ec useby date. Medical device directive mdd 9342eec as amended by 200742 ec pavan kumar malwade 01 april 2016 1 2.

Since directive 2007 47 ec is addressed to the member states, preliminary transposition into national law is indispensable for the application of the corresponding provision by the various economic operators. Medical devices directive 9342eec as amended by eu council directive 200747 ec of 5th september 2007. 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. Council directive 9342eec of 14 june 1993 concerning medical devices, last amended by directive 200747 ec. Directive 200747 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988 ec concerning the placing of biocidal. Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, last amended by directive 200747 ec. Changes are sweeping european medical device regulations, and they will affect every company that markets devices in europe. So it is quite easy to spot all the changed sections of the directive. A 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. Medical device directive mdd including amendments, the latest being directive 200747 ec, published as a consolidated text at.

Impact of directive 200747ec on future ce marking audits. This clarifies a point that was not clear in directive 200747 ec. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Changes to the medical device legislation in europe the impact of directive 200747 ec slideshare uses cookies to improve functionality and performance, and to. 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. This highly revealing interactive course lays out the principal sections of the medical device directive 9341eec and subsequent updates up to 200747 appropriate to clinical. Directive 200747 ec of the european parliament and of the council of 5 september. Directive 2007 47 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988 ec concerning the placing of biocidal. Medical device currently placed on the market with the ce marking of conformity where ecpc is altered by amending directive 200747 ec amending directive alters the ecpc of certain medical devices placed on the market according to council directive 9342eec, consequently such. On 21 september 2007, the european commission published an amendment to the medical device directives 9042eec and 90385eec. Questions relating to the implementation of directive 200747 ec 1. Medical device directive 9342eec, active implantable medical devices directive 90385eec and biocidal products directive 988 ec.

Compliance of medical devices with the new requirements. Changes to definitions medical software software specifically for diagnostictherapeutic use is a medical device however software intended for general page 10 purposes, when used in a healthcare setting is not a medical device recital 6 of 200747 ec stand alone medical software. The following consecutive amendments to directive 200746 ec are taken into account as well. Compliance with the revised directive became mandatory on 21 march 2010. Sg4n33r16 regulatory audit reports 90385eec 2007 active implantable medical device directive leave a reply cancel reply your email address will not be published. Council directive 9342eec of 14 june 1993 concerning medical devices. The amendments to the mdd has been published a number of additional directives amending the original directive has been introduced, the recent revising directive 2007 47 ec is amending of the directive 90385eec concerning active implantable medical devices, directive 9342eec concerning medical devices and directive 988 ec concerning the. Directive 2007 47 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988 ec concerning the placing of biocidal products on the market text with eea relevance. The bottom line of the amendment is that every medical device sold in europe, regardless of its classification, must have a clinical evaluation ce report in its. Phthalates of concerns and the medical device directive 9342eec. As i promised, i finally did all the changes of the 200747 ec directive to the previous version of the mdd. European medical device directive essential requirements.

Electromagnetic compatibility to emc directive 201430eu electrical safety to low voltage directive 201435eu we, vicon motion systems limited unit 6, oxford industrial park mead road, yarnton, oxford, ox5 1qu united kingdom. The amendments to the mdd has been published a number of additional directives amending the original directive has been introduced, the recent revising directive 200747 ec is amending of the directive 90385eec concerning active implantable medical devices, directive 9342eec concerning medical devices and directive 988 ec concerning the. Is required for all devices regardless of classification, i. Questions relating to the implementation of directive 2007 47 ec 1. The medical devices directive is being repealed and replaced by the 2017 eu medical device regulation eu 2017745, effective on 26 may 2020. Directive 200747ec of the european parliament and of the. Recital 6 of directive 200747 ec states that it is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

View the medical devices directive description, purpose. As you are probably aware, eu directive 2007 47 ec modifies the medical devices and active implantable medical devices directives, and must be applied starting 21 march 2010. The european commission guidance indicates that on 21 march 2010 medical devices placed on the market at that time must comply with directive 200747 ec. Medical devices directive 9342eec pdf download 10yi83. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22. Council directive 9342eec concerning medical devices and directive 988ec concerning the placing of. Conformity to the revised directive became mandatory on march 21, 2010. Directive 200747ec of the european parliament and of the council of 5. This means that its implementation becomes mandatory on march 21st, 2010. The impact of directive 200747ec linkedin slideshare.

Ce marking in medical devices, 9342at, 200747ec szutest. As you are probably aware, eu directive 200747ec modifies the medical devices and active implantable medical devices directives, and. Software for general purposes when used in a healthcare setting is not a medical device. The new directive 200747 ec introduces substantial changes to. In order words, after march 21, 2010, the ce marking. The major areas of change implemented under mdd 2007 47 ec are as follows. The medical device directive is intended to harmonise the laws relating to medical devices. 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. Examination of interpretation document on amending.