93 42 ewg medical device directive pdf

Operating instructions speedy easyrunning, rigidframe wheelchair subject to ec directive 9342 ewg for medical devices printed in germany 072010. For products classified with medium to high degree of risk class is, im, iia, iib and iii the medical device directive requires a conformity assessment procedure involving a notified body. The ce marking directive 9368eec ce marking association. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. 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. Eu medical device directive 9342eec labelling requirements. Iia, according to annex ix of directive 9342eec marking. Medical device directive 9342eec cemarking qnet, llc. According to directive 200747ec which, will become mandatory on 21 march 2010, has amended the directive 9342eec, medical device means. The mdr will replace the current eus medical device directive 9342eec and the eus directive on active implantable medical devices 90385eec. Eu medical device directive 93 42 eec labelling requirements sterile barrier association, pennygate house, st weonards, herefordshire, hr2 8pt, uk tel 01981 580 190 mailto. Council directive 9342eec of 14 june 1993 concerning medical devicesintroduction introductionarticle 1 definitions, scopearticle 2 placing on the market and putting into servicearticle 3 essential requirementsarticle 4 free movement, devices intended for special purposesarticle 5 reference to standardsarticle 6 committee on standards and technical regulationsarticle 7 article. Directive 6565eec device thatbeshall governedby the, presentdirective withoutprejudice thetoprovisions of.

List european harmonized standards for the medical devices. Medical product regulation states that medical products can be freely handled on the european market as long as they fulfill basic requirements. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. To implement our quality policy relating to the manufacturing of medical devices, our company introduced and maintains a processoriented quality management system in accordance with din en iso 485. The definition of the term medical device together with the definition of accessory is determinant for the delimitation of the field of application of directive 9342eec. According to mdd annex ix 9342eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies. 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. The essential requirements of the medical device directive 9342 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to. Medical device directive 9342 ewg mdd the mdd is the medical device directive or 93 42 eec. Registered in england under the industrial friends and provident society no.

December 2001 amending council directive 9342eec concerning medical devices commission directive 200332 ec pdf, 123 kb of 23 april 2003. Please find the latest consolidated ivdd 9879ec below. 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. Eu mdr links quadras regulatory affairs service medical. The directives 90385 ewg aimd and 9342ec mdd have been changed by directive 200747ec of the european parliament and the council of 5 september 2007. 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. Classification criteria definitions for the classification rules. The software sra24 is a medical device from in house production and exclusively determined for use in our health facility and for providing our service. On friday 27 april 2012, the european commission published updated lists of the european harmonized standards that pertain to the medical devices directive 93 42 ec, in vitro diagnostics directive 9879ec, and the active implantable medical devices directive 90385eec. The revision of the medical devices directive 9342eec. Council directive 93 42 eec of 14 june 1993 concerning medical devicesintroduction introductionarticle 1 definitions, scopearticle 2 placing on the market and putting into servicearticle 3 essential requirementsarticle 4 free movement, devices intended for special purposesarticle 5 reference to standardsarticle 6 committee on standards and technical regulationsarticle 7 article. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. According to mdd annex ix 93 42 eec rule 1 all noninvasive devices are in class i, unless one of the rules set out hereinafter applies.

Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and. Mds 7004 medical devices referencing the directive 200642ec on machinery creation date. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 9342eec annex ix. Directive 93 68eec ce marking directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. How are medical devices regulated in the european union. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. This document is available in either paper or pdf format. 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. The directive 9342eec applies for the placing on the market and launching of medical devices and their accessories. Council directive 93 42 eec of 14 june 1993 concerning medical devices. The ivd directive was amended and corrected over time. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.

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. Valid from 20180705 valid until 20230704 registration no. The ec declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 of the directive ensures and declares that the products concerned meet the provisions of the directive which apply to them. Rule 2 all noninvasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion. European medical device directive essential requirements. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Ecdirective 9342 ewg mdd eucommission pdf commission recommendation 20473eu on the audits and assessments performed by notified bodies in the field of medical devices pdf.

Medical device directive mdd 9342eec as modified by 200747ec. We hereby declare under our sole responsibility that the designated device and its accessories, which are listed in the technical documentation for this device and whose conformity has been assessed together with the device, conform to the medical device directive council directive 9342eec. M5 stand alone software is considered to be an active medical device. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. Medical devices directive 9342eec mdd and subsequent amendments. In europe, following the recent medical device directive changes medical device reporting mdr 2017745 25, a bone adhesive is automatically class 3 and so human clinical data collection is. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the.

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. Full text of the european medical devices directive 93 42 eec including amendments by 200747ec. In addition to this, we are committed to meeting the requirements of the medical device directive 9342eec and proving conformity. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Annex 9 directive 9342eec amended, concerning medical devices. The mdr will replace the current eus medical device directive 93 42 eec and the eus directive on active implantable medical devices 90385eec. European medical device directive essential requirements checklist. Pdf the new european medical device regulation 2017745. Medical device directive 9342 eec since the 14th june of 1998 each medical device must carry a ce mark. Medical devices directive mdd 9342eec explained in the medical device directive m. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. The medical device regulation mdr has entered into force on may 26th 2017. Medical device directive mdd 93 42 eec as modified by 200747ec. P1800452117481 stuttgart 20180627 head of certification body.

The content of this page deals only with the medical devices directive 93 42 eec. Certificates issued by notified bodies with reference to the council directives 93 42 eec on medical devices mdd, 90385eec on active implantable medical devices aimdd, both amended by directive 200747ec, and 9879ec on in vitro diagnostic medical devices ivdd are important documents to all parties involved. 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. Directive 9342eec on medical devices mod, annex vi devices in class i with measuring function no.

B council directive 9342eec of 14 june 1993 concerning. Directive 93 42 eec concer ning medical devices oj l 28, 4. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. European national states must translate this directive into national law.

Essential requirements medical devices directive applicable yn applied standards, procedures, justification evaluati. Disinfectants for use on medical devices and test strips the following ce label can be applied to these products mentioned in the appendix of this certificate ce 1250 a condition for the validity of this certificate is a regular examination in accordance with annex ii. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. Reporting changes to your notified body vicky medley head of qms, medical devices. Medical device directive 9342eec annex ii, excluding section 4 classification. The surveillance will be held as specified in annex v, section 4. Medical devices directive mdd 9342eec active implantable medical devices aimd 90385eec. Ce marking and european medical device directive 93 42 cee. Normally intended for continuous use for more than 30 days. European medical devices directive 9342eec with 200747ec. The devices must be designed, manufactured and packed in such a way that their characteristics and. 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. Active therapeutical device any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace. Zipfile structure of technical documentation 2017745 mdr and mdd 9342 ewg rev.

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. Council directive 9342eec of 14 june 1993 concerning medical devices. Ce marking and european medical device directive 9342cee. Certificates issued by notified bodies with reference to the council directives 9342eec on medical devices mdd, 90385eec on active implantable medical devices aimdd, both amended by directive 200747ec, and 9879ec on in vitro diagnostic medical devices ivdd are important documents to. Classification criteria definitions for the classification. Medset eg certificate 93 42 ewg en 20162019 20190726k. Overview a medical device is defined in directive 93 42 eec as. This quality assurance system covers those aspects of manufacture concerned with the metrological requirements of the respective devices i device categories and conforms to the requirements of this directive. Directive 9342eec covers the placing on the market and putting into service of medical devices within the framework of ce marking. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Ecdirective 200747eg modification of mdd and aimd eukommission pdf egdirective 200550eg reclassification joint replacements eucommission. Directive 200070ec of the european parliament and of the council of 16 november 2000. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for.

Devicesdevice categories included in the certificate class il a. Interactive web page allows for inpage navigation from section to section. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Directive 6565eec device thatbeshall governedby the. All medical devices are placed into one of four graduated categories, using the classification rules listed in directive 93 42 eec annex ix. Guidance for submission and conduct of a clinical investigation with a medical device or a performance evaluation with an in vitro diagnostic in accordance with. Classification according to annex ix directive 9342 ewg. A slight difference exists between the definition in article 12 a of directive 9342eec and in article 12 of directive 90385eec. Medical devices internal market, industry, entrepreneurship.

This device complies with the requirements of the medical device directive 9342 eec. Annex ii directive 9342eec without section 4 this appendix is valid only in connection with the following certificate. May 27, 2011 when medical device companies do business in europe, they are required to conform to the eus medical device directive, 9342eec one important way to comply is to use the applicable standards from the harmonised list for medical devices. The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device.

Registration number 39955 validity from may 4, 2018 up to and including may 3, 2021 this approval includes the following medical devices. Easyrunning, rigidframe wheelchair subject to ec directive 9342 ewg for medical devices printed in germany 072010. Basic information about the european directive 9342eec. European directive 9342eec, annex ii document id dokument nr. Medical devices directive 9342ec evaluation and testing. Manufacturers of currently approved medical devices will have a transition time of three years until may 26th 2020. Council directive 9342eec of 14 june 1993 concerning medical devices this document comes with our free notification service, good for the life of the document.

The manufacturer confirms conformity of a medical product with basic requirements by labeling every single product with the ce mark. New european regulation for medical devices to replace 9342. These sections are reproduced below for your information or. Easyrunning, folding wheelchair subject to ec directive 9342 ewg for medical devices printed in germany 072010. The number indicates the year of initial release 1993 and the consecutive number of directives in that year.