Direttiva 2007 47 ce software

If the device is not intended to be used solely or principally in a specific. Dlgs 372010 attuazione della direttiva 200747ce che modifica le. Software this will now be considered an active medical device, whether integral with the device or as a standalone product. Directive 2007 64ec of the european parliament and of the council of november 2007 on payment services in the internal market amending directives 977ec, 200265ec, 200560ec and 200648ec and repealing directive 975ec text with eea relevance the european parliament and the council of the european union. Directive 2007 47 ec was published in the official journal of 21 september 2007 and entered into force on the 20th day following this publication, i. Directive 200695 ec came into force and repealed directive 7323ec as from 16th january 2007. Europa guidelines on the application of directive 200695ec. Nuove direttive di prossima applicazione riguardanti i generatori di acqua calda per riscaldamento e sanitario direttiva erp. The ce marking should be fully recognised as being the only marking which guarantees that machinery conforms to the requirements of this directive. The directives division administers and operates the dod issuances program, the dod information collections program, dod forms management program, gao affairs, and the dod plain language program for the office of the secretary of defense. I fabbricanti, quindi, devono tener conto delle regole in essa definite in modo da garantire i requisiti minimi di sicurezza e affidabilita.

Classification criteria definitions for the classification. Direttiva 201227ue del parlamento europeo e del consiglio del 25 ottobre 2012 sullefficienza energetica, che modifica le direttive 2009125ce e 201030ue e abroga le direttive 20048ce e. Dispositivi medici 9342cee, integrata dalla direttiva 200747ce. Direttiva 2002 47 ce del parlamento europeo e del consiglio, del 6 giugno 2002, relativa ai contratti di garanzia finanziaria gazzetta ufficiale n. This commission department is responsible for eu policy on justice, consumer rights and gender equality. Auditing gxp critical computerized systems isaca italia february, 17, 2010. I prodotti conformi alla direttiva md devono essere contrassegnati con il marchio ce. It should be noted that the content is also identical to the previous directive.

Interactive web page allows for inpage navigation from section to section. Directive 200747ec 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. L 11464 it gazzetta ufficiale dellunione europea 27. Ai fini della direttiva 200439ce e della presente direttiva, 47 sione alla negoziazione di strumenti finanziari e che. Direttiva 9342cee eu 2017745 primolab software per.

Pagina data m1 directiva 200764ce a parlamentului european. Il presente decreto legislativo intende garantire che i prodotti immessi sul mercato ovvero in libera pratica siano sicuri. Directive 200687 ec objectives of directive 200687 ec. Direttiva ue 200746ce omologazione veicoli a motore.

Establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles framework directive. 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. European representative the new ec directive 200747ec will allow manufacturers to only have one european repre. Direttiva 0747ce il marzo 2010 in gazzetta ufficiale e stato pubblicato il decreto legislativo n. The transposition by the member states was due by 21 december 2008. Attuazione della direttiva 90385cee concernente il. It is necessary to clarify that software in its own right, when. As you are probably aware, eu directive 200747ec modifies the medical devices and active implantable medical devices directives, and must be applied starting 21 march 2010. Direttiva 9342cee riguarda i dispositivi medici recepita in italia con il dlgs n. All devices being put on the market in the eu after rd june 1998 must bear ce marking. Dlgs 372010 attuazione della direttiva 200747ce che. Full text of the european medical devices directive 9342eec including amendments by 2007 47 ec.

Ce marking for european directives european regulatory language requirements 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 which. Directive 200695 ec is a codifying directive which brings together in one text the original low voltage directive 7323eec6 with its subsequent amendments. Directive 2001104ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. Dispositivi medici direttiva 9342cee regolamento 2017745ue. Request more information from our specialists contact us. Feb 25, 2015 idrotech sas informativa tecnico commerciale. Next to requirements regarding the design, the machinery directive also states demands regarding the documentation. Classification criteria definitions for the classification rules. Ce marking for european directives the language center. The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. Vinje on may 14, 1991, the council of ministers council of the euro. Direttiva 200747ce direttiva 200747ce del parlamento europeo e. Il software primolab consente di effettuare ladeguamento alla direttiva 9342cee e d.

The ec directive on the legal protection of computer. This blog lists the requirements from the machinery directive on the manual. Directive 200747ec changes to the medical devices directive. Oct 28, 2015 direttiva 9342cee riguarda i dispositivi medici recepita in italia con il dlgs n. Questions relating to the implementation of directive 200747 ec 1. Coopera direttiva 20039ce legge comunitaria 2003 norme minime relative allaccoglienza dei richiedenti asilo negli stati membri a cura del gruppo di lavoro docenti giurisprudenza luisa. Medical devices internal market, industry, entrepreneurship. Ruocco direttore generale farmaci e dispositivi medici ministero salute 1 introduzione alla direttiva 200747ce. The data protection directive is being phased out and will be taken over by general data protection regulation gdpr in january 2012, the european commission submitted a draft proposal for a comprehensive reform of data protection rules in the eu.

If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. Netgear rangemax dual band wirelessn usb adapter wnda3100. Modular safety integrated controller mosaic 1 8540780 30th july 20 rev. Direttiva ue 200746ce omologazione veicoli a motore e rimorchi. Directives division washington headquarters services. Determine if your machine falls within the scope of. By affixing the ce mark, you declare that your machine complies with the machinery directive and possibly other ce guidelines. Dispositivi medici direttiva 9342cee eurofins product testing italy puo. Directive 200747ec guidance document for mdd 9342eec. Under the terms of the medical device directive a competent authority is nominated by the government of each member state to monitor and ensure compliance with its provisions. Guideline major inspections of mobile elevating work. European medical devices directive 9342eec with 200747ec.

Il regolamento dispositivi medici ue 2017745 mdr certifico srl. According to the second subparagraph of article 41 of directive 2007 47 ec, the member states shall. Rule 3 all noninvasive devices intended for modifying the. Direttiva 2002 47 ce del parlamento europeo e del consiglio.

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. Compliance of medical devices with the new requirements. Implementazione della direttiva 200060ce classificazione dello stato ecologico dei corpi idrici delle acque marino costiere a cura di. The ec hoped that through creation of a single, euwide law, fragmentation and expensive administrative measures associated with. Recepimento della direttiva 200730ce e semplificazione. All cemarked products placed on the market from march 21, 2010 on will need to be covered by a new declaration of conformity. Direttiva 200768ce della commissione del 27 novembre 2007. 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. To set up a harmonised system of technical requirements updated after almost 25 years in accordance with the highest safety standards for inland waterway vessels including passenger vessels valid for navigation on all community inland waterways, including the rhine. Direttiva 200746ce del parlamento europeo e del consiglio del 5 settembre 2007. Applicability of directive 200687ec to commercial and. Il presidente della repubblica omissis e m a n a il seguente decreto legislativo. Directive 200747ec of the european parliament and of the council of 5 september 2007.