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Language Requirements for the EEA

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download LR5-05.pdf

This document describes the language requirements for the European Economic Area (EEA) and the European Free Trade Area (EFTA).

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Guidance Document on the relationship between the GPSD and certain Sector Directives

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download guidance_gpsd_en.pdf

Guidance Document on the Relationship Between the General Product Safety Directive (GPSD) and Certain Sector Directives with Provisions on Product Safety

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European Guidelines - Blue Guide

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download blue_guide.pdf

This is the Guide to the implementation of directives based on the New Approach and the Global Approach

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Amendement to Medical Directives

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download Amendment_to_Medical_Directives_1.pdf

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/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 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)

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Cosmetic Catalog V5

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IVD Catalog V5

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PPE Catalog V1

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LVD Catalog V1

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EMC Catalog V1

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MDD / IVD Chinese Catalog

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Obelis O.E.A.R.C is proud to announce the 1st release of its Chinese Catalogues. You will find very useful information about MDD/IVD notification procedures, CE marking, and other services. These are sample pages from both MDD/IVD catalogues. If you wish to receive the full version of these catalogues for free by e-mail, please contact us, and we guarantee a delivery in 24 hours

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MDD Spanish Catalog

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US Agent Catalog

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These are sample pages of Obelis O.E.A.R.C. USAgent V.4 catalogue if you wish to receive the full version of this catalogue for free by e-mail, please contact us, and we guarantee a delivery in 24 hours.

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