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European Directives Legislation

27 European States' Interpretations of these selected items are available via request. In order to get your free interpretation of country of your choice, please email us your name, organization, address and phone number

Reference Name View Directive Info References harmonised standards
GENERAL DIRECTIVES: - HTML
(EC) No 207/2009 Regulation on the Community Trade Mark PDF
2006/114/EC Directive concerning misleading and comparative advertising PDF
2010/227/EU Commision Decision on EUDAMED PDF
93/68/EEC CE Marking Directive PDF
2001/95/EC GPSD Directive PDF link link
2012/19/EU WEEE Directive PDF
2011/65/EU RoHS Directive PDF
(EC) No 1907/2006 REACh Regulation PDF
765/2008 Regulation on Accreditation and Market Surveillance Relating to Marketing of Products (New Approach) PDF
768/2008/EC Decision on a Common Framework for the Marketing of Products (New Approach) PDF
SPECIFIC DIRECTIVES: - HTML
93/42/EEC & 2007/47/EC Medical Device Directive Consolidated Version PDF
90/385/EEC & 2007/47/EC Active Implantable Medical Device Directive Consolidated Version PDF link
93/42/EEC Medical Devices Directive (MDD) PDF link link
EU/207/2012 Regulation on Electronic instructions for Medical Devices PDF
722/2012 Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin PDF
98/8/EC Biocide Products Directive PDF
EC 1451/2007 Biocide Products Regulation PDF
2007/47/EC Amendment to 90/385/EEC, 93/42/EEC & 98/8/EC PDF
98/79/EEC In-Vitro Diagnostic Directive (IVDD) PDF link link
1223/2009/EC Cosmetic Product Regulation PDF link
76/768/EEC Cosmetic Product Directive PDF link
2012/21/EU Amendment Directive to Annex II & III of Directive 76/768/EEC PDF
2011/59/EU Amendment Directive to Annex II & III of Directive 76/768/EEC PDF
2011/84/EU Amendment Directive to Annex II & III of Directive 76/768/EEC_Tooth Whitening Products Directive PDF
89/686/EEC Personal Protective Equipment Directive (PPE) PDF link link
2004/108/EC Electromagnetic Compatibility Directive (EMC) PDF link link
2006/95/EC Low Voltage Equipment Directive (LVD) PDF link link
1999/5/EC Radio and Telecommunications Terminal Equipment Directive (R&TTE) PDF link link
2009/48/EC Toy Safety Directive PDF link link
88/378/EEC Toy Safety Directive (TSD) PDF link link
2006/42/EC Machinery Safety Directive PDF link link
2004/22/EC Measuring Instruments Directive PDF
305/2011/EU Construction Products Regulation PDF
89/106/EEC Construction Products Directive (CPD) PDF link link
95/16/EC Lifts Directive PDF link link
2000/9/EC Cableway Installations Designed to Carry Persons Directive PDF link link
97/23/EC Pressure Equipment Directive (PED) PDF link link
87/404/EEC Simple Pressure Vessels Directive PDF link link
94/9/EEC Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX) PDF link link
93/15/EEC Explosives for Civil Use Directive HTML link link
90/384/EEC Non-Automatic Weighing Instruments Directive PDF link link
2007/46/EC Motor Vehicle Directive PDF
70/156/EEC Motor Vehicle Directive (MVD) PDF
94/25/EEC Recreational Crafts Directive PDF link link
GUIDANCE DOCUMENTS: - HTML
2012.542 Commission Proposal for Medical Device Regulation PDF
2012.541 Commission Proposal for In-Vitro Diagnostic Medical PDF
MEDDEV Guidelines on Qualification and Classification of Stand Alone Software PDF
MEDDEV Guidance on Authorized Representative PDF
MEDDEV Guidelines for the classification of Medical Devices PDF
- Guide to the Implementation of Directives Based on the New Approach and the Global Approach PDF
MEDDEV MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES HTML
MEDDEV CERTIF 2005–16 Rev. 2: Elements for a Horizontal Legislative Approach to Technical Harmonizati PDF
MEDDEV Guidance Document - Translation procedures PDF
MEDDEV Supply of Instructions for use for IVD Medical Devices PDF
MEDDEV Guidelines for Conformity Assesment of IVF and ART Products PDF
MEDDEV Guidelines on a Medical Devices Vigilance System Rev. 8 PDF
MEDDEV Guidelines on Medical Devices A guide for Manufacturers and Notified Bodies PDF
- Draft Commission Regulation on electronic instructions for use of medical devices PDF
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