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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 | |||
| 2006/114/EC | Directive concerning misleading and comparative advertising | |||
| 2010/227/EU | Commision Decision on EUDAMED | |||
| 93/68/EEC | CE Marking Directive | |||
| 2001/95/EC | GPSD Directive | link | link | |
| 2012/19/EU | WEEE Directive | |||
| 2011/65/EU | RoHS Directive | |||
| 768/2008/EC | Decision on a Common Framework for the Marketing of Products (New Approach) | |||
| 765/2008 | Regulation on Accreditation and Market Surveillance Relating to Marketing of Products (New Approach) | |||
| SPECIFIC DIRECTIVES: | - | HTML | ||
| 93/42/EEC & 2007/47/EC | Medical Device Directive Consolidated Version | |||
| 90/385/EEC & 2007/47/EC | Active Implantable Medical Device Directive Consolidated Version | link | ||
| 93/42/EEC | Medical Devices Directive (MDD) | link | link | |
| EU/207/2012 | Regulation on Electronic instructions for Medical Devices | |||
| 722/2012 | Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin | |||
| 98/8/EC | Biocide Products Directive | |||
| EC 1451/2007 | Biocide Products Regulation | |||
| 2007/47/EC | Amendment to 90/385/EEC, 93/42/EEC & 98/8/EC | |||
| 98/79/EEC | In-Vitro Diagnostic Directive (IVDD) | link | link | |
| 1223/2009/EC | Cosmetic Product Regulation | link | ||
| 76/768/EEC | Cosmetic Product Directive | link | ||
| 2012/21/EU | Amendment Directive to Annex II & III of Directive 76/768/EEC | |||
| 2011/59/EU | Amendment Directive to Annex II & III of Directive 76/768/EEC | |||
| 2011/84/EU | Amendment Directive to Annex II & III of Directive 76/768/EEC_Tooth Whitening Products Directive | |||
| 89/686/EEC | Personal Protective Equipment Directive (PPE) | link | link | |
| 2004/108/EC | Electromagnetic Compatibility Directive (EMC) | link | link | |
| 2006/95/EC | Low Voltage Equipment Directive (LVD) | link | link | |
| 1999/5/EC | Radio and Telecommunications Terminal Equipment Directive (R&TTE) | link | link | |
| 2009/48/EC | Toy Safety Directive | link | link | |
| 88/378/EEC | Toy Safety Directive (TSD) | link | link | |
| 2006/42/EC | Machinery Safety Directive | link | link | |
| 2004/22/EC | Measuring Instruments Directive | |||
| 305/2011/EU | Construction Products Regulation | |||
| 89/106/EEC | Construction Products Directive (CPD) | link | link | |
| 95/16/EC | Lifts Directive | link | link | |
| 2000/9/EC | Cableway Installations Designed to Carry Persons Directive | link | link | |
| 97/23/EC | Pressure Equipment Directive (PED) | link | link | |
| 87/404/EEC | Simple Pressure Vessels Directive | link | link | |
| 94/9/EEC | Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX) | link | link | |
| 93/15/EEC | Explosives for Civil Use Directive | HTML | link | link |
| 90/384/EEC | Non-Automatic Weighing Instruments Directive | link | link | |
| 2007/46/EC | Motor Vehicle Directive | |||
| 70/156/EEC | Motor Vehicle Directive (MVD) | |||
| 94/25/EEC | Recreational Crafts Directive | link | link | |
| GUIDANCE DOCUMENTS: | - | HTML | ||
| 2012.542 | Commission Proposal for In-Vitro Diagnostic Medical Devices Regulation | |||
| 2012.541 | Commission Proposal for Medical Device Regulation | |||
| MEDDEV | Guidelines on Qualification and Classification of Stand Alone Software | |||
| MEDDEV | Guidance on Authorized Representative | |||
| MEDDEV | Guidelines for the classification of Medical Devices | |||
| - | Guide to the Implementation of Directives Based on the New Approach and the Global Approach | |||
| 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 | |||
| MEDDEV | Guidance Document - Translation procedures | |||
| MEDDEV | Supply of Instructions for use for IVD Medical Devices | |||
| MEDDEV | Guidelines for Conformity Assesment of IVF and ART Products | |||
| MEDDEV | Guidelines on a Medical Devices Vigilance System Rev. 8 | |||
| MEDDEV | Guidelines on Medical Devices A guide for Manufacturers and Notified Bodies | |||
| - | Draft Commission Regulation on electronic instructions for use of medical devices |
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