93 43 eec pdf download

By continuing to browse this website you agree to the use of cookies. Manufacturers must comply with the medical device directive, mdd 9342eec, in order to sell their medical products into europe. 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. What the proposed mdd revision means to medical device manufacturers with each significant change covered pointbypoint. Council directive 9243eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora. Medical devices internal market, industry, entrepreneurship. Significant changes ahead for medical device manufacturers. In 1985, a series of new approach principles were introduced into the european community ec that would enable the free movement of goods across the region. Communication from the commission to the council in accordance with article 1 of directive 91628eec. Understanding the machinery directive 2006 42ec brief history. You can download the complete directive in pdf by cliquing on the following link. The habitats directive environment european commission.

However, a fundamental revision of those directives is needed to establish a robust. 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. Council directive 92 43 eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora. 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. 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. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Under the 93 43 eec directive, the manufacturer is responsible for the quality of products placed on the market and the standard of hygiene throughout all stages of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer. Food law code of practice england april 2014 page 7 food authorities must also have regard to the framework agreement on local authority food law enforcement the framework agreement,3 which reflects the requirements of this code. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec and it often causes confusion, as its purpose is not overly clear. 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. The medical device directive 93 42 eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used. Pdf evaluation of the impact of actions implementing.

Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereofhaving, regard tothe proposalfromthe commission, incooperation withthe2european parliament, havingregard totheopinion oftheeconomic socialand committeewhereas3,measures shouldbe adoptedin the contextof. The revision of the medical devices directive 9342eec. Evaluation of the impact of actions implementing regulation eec no 201993 on the economic situation of the small islands in the aegean sea. Adopted in 1992, the council directive 9243eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora aims to promote the maintenance of biodiversity, taking account of economic, social, cultural and regional requirements. Proposal for a council directive amending directive 9375eec concerning minimum requirements for vessels bound for or leaving community ports and carrying dangerous or polluting goods. 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 active implantable medical devices, council directive 9342eec concerning medical devices and directive 988ec concerning the placing of biocidal. B council directive 9343eec of 14 june 1993 on the. Be careful not to let metal objects get into the equipment. 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. Due to the covid19 pandemic many businesses are closed for deliveries. Directive 89336 eec,2 amended by directives 91263eec3, 9231eec4, 93 68eec5 and 93 97eec6 concerning electromagnetic compatibility, with a view to compiling a guide for use in conjunction with the directive. Connecting devices with 100 to 240 v ac power supply. Food safety control handbook of food science and technology.

Gpc is cooperation partner of mit for cemdd certification for china. Directive 9368eec and low voltage directive 7323 eec. All bsi british standards available online in electronic and print formats. Council decision of 22 july 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ce conformity marking, which are intended to be used in the technical harmonization directives official journal l 220, 30081993 p. Directive 9879ec of the european parliament and of the council of. Council of the european communities directive 9341eec of 14 june 1993 repealed directive 8722eec on the approximation of national measures relating to the marketing of hightechnology medicinal products, as this directive had been superseded by council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products. F2 labs can perform the emc and safety testing that is required by the medical device directive for medical electrical products. The medical device directive 9342eec defines a medical device as any instrument, apparatus, appliance, material or other article, whether used. The mdr will replace the current eus medical device directive 93 42 eec and the eus directive on active implantable medical devices 90385 eec. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs. Essentially it was introduced to amend existing directives for them to include the requirement to affix the ce mark. 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.

Proposal for a council directive amending directive 91628. 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. B council directive 9342eec of 14 june 1993 concerning. Directive 200747ec guidance document for mdd 9342eec. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. The ce marking directive 9368eec ce marking association. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the. Council directive 9343eec on the hygiene of foodstuffs. Council directive 9385eec of 4 october 1993 on the control. It forms the cornerstone of europes nature conservation policy with the birds directive and. Under the 9343eec directive, the manufacturer is responsible for the quality of products placed on the market and the standard of hygiene throughout all stages of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer.

Proposal for a council directive amending directive 9375. Directive 200070ec of the european parliament and of the council of 16 november 2000. Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs eu law. Here you can download documents, technical product manuals and graphic files. Council directive 9342eec of 14 june 1993 concerning. Council direci1ve 9336eec of 14 june 1993 coordinating procedures for the award of public supply contracts 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 i. Also, ce mark which is attached to our companys products of battery operated apparatus means it conforms to emc. 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 council directive 9342eec on medical devices mdd. Contents of technical documentation for mdd 9342eec and. Tuv sud offers services required under the european union medical device directive, 9342eec, including the auditing of a manufacturers quality system. We have 3 siemens scalance xr3244m eec manuals available for free pdf download.

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. In view of the breadth of the scope of the directive and the variety of products covered, it. The medical device regulation mdr has entered into force on may 26th 2017. Why the revision of the medical devices directive 93 42 eec mdd was necessary and what the regulators have looked at changing. Medical devices directive 9342ec evaluation and testing.

The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 93 42 eec and the active implantable medical devices directive aimdd 90385 eec. Council directive 9342eec of 14 june 1993 concerning medical devices. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Council directive 9383eec of 27 september 1993 on the coordination of certain rules concerning and rights related to applicable to satellite broadcasting and cable retransmission is a european union directive which governs the application of and related rights to satellite and cable television in the european union.

Council directive 9343eec of 14 june 1993 on the hygiene of foodstuffs 5 laid down the general rules of hygiene for food stuffs and the. Council directive 9385eec of 4 october 1993 on the control of potato ring rot the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 43 thereof, having regard to the proposal from the commission1. 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. 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. Directive 9368ec introduced the harmonized provisions related to ce marking. Regulation ec no 8522004 food safety authority of ireland. This document is available in either paper or pdf format. Right click on the link below to download to your computer select save target as ivdd 9879ec in pdf format status. Interreg central europe is a european union funding programme that inspires and supports cooperation on shared regional challenges with a budget of 246 million euro from the european regional development fund erdf.

Directive 93 44 eec, which expanded the scope of the machinery directive to. Megasquirt pnp gen2 documentation modelvehicle specific installation guide for model mspnp2eec4a8 for a 19841993 ford mustang 5. Unspecified 1993 proposal for a council directive amending directive 91628eec concerning the protection of animals during transport. This item of legislation is only available to download and view as pdf. Ec declaration of conformity directive 7323eec, 9368eec. 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. B council directive 9343eec of 14 june 1993 on the hygiene. Please ensure your ship to address is able to receive your purchase. Pdf habitats directive 9243eec fish species osteichthyes on. Council directive 9343eec of 14 june 1993 on the hygiene of. We use cookies and similar technologies to give you a better experience, improve performance, analyze traffic, and to personalize content. Where to find the initial public consultation text, eucomed reaction and proposed mdd revision. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.

Certification information download international certification trends. 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. Directive 201468eu of the european parliament and of the. 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. 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 of biocidal. The european commission has issued an interpretative document dated 5 june 2009 of directive 200747ec which amends the medical devices directive mdd 9342eec and the active implantable medical devices directive aimdd 90385eec. The freevent accessories ref name class gmdn code 1502 stoma oil 100ml iib 57897 1601. Mdd 9342eec essential req 20170624 sam lazzara clinical evaluation, design control, europe leave a comment 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. Food law code of practice england university of reading. Council directive 9343eec of 14 june 1993 on the hygiene. The medical device directive council directive 9342eec 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. If something does slip into the equipment, unplug the ac adaptor from the wall outlet. 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.