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
2010/227/EU	Commision Decision on EUDAMED	PDF
93/68/EEC	CE Marking Directive	PDF
2001/95/EC	GPSD Directive	PDF	link	link
2011/65/EU	RoHS Directive	PDF
768/2008/EC	Decision on a Common Framework for the Marketing of Products (New Approach)	PDF
765/2008	Regulation on Accreditation and Market Surveillance Relating to Marketing of Products (New Approach)	PDF
SPECIFIC DIRECTIVES:	-	HTML
93/42/EEC & 2007/47/EC	Medical Device Directive Consolidated Version	PDF
2007/46/EC	Motor Vehicle Directive (MVD) new	PDF
93/42/EEC	Medical Devices Directive (MDD)	PDF	link	link
70/156/EEC	Motor Vehicle Directive (MVD)	PDF
2007/47/EC	Amendment to 90/385/EEC, 93/42/EEC & 98/8/EC	PDF
305/2011/EU	Construction Products Regulation	PDF
98/79/EEC	In-Vitro Diagnostic Directive (IVDD)	PDF	link	link
2006/42/EC	New Machinery Safety Directive 2006/42/EC	PDF
90/385/EEC & 2007/47/EC	Active Implantable Medical Device Directive Consolidated Version	PDF	link
98/37/EC	Machinery Safety Directive 98/37/EC	PDF
90/385/EEC	Active Implantable Medical Devices Directive	PDF	link	link
76/768/EEC	Cosmetics Products Directive	PDF	link
2011/84/EU	Tooth Whitening Products Directive	PDF
1223/2009/EC	Cosmetic Regulation NEW	PDF	link
97/23/EC	Pressure Equipment Directive (PED)	PDF	link	link
95/16/EC	Lifts Directive	PDF	link	link
2006/42/EC	Safety of Machinery and Amendments to the Lifts Directive	PDF	link	link
1999/5/EC	Radio and Telecommunications Terminal Equipment Directive (R&TTE)	PDF	link	link
2000/9/EC	Cableway Installations Designed to Carry Persons Directive	PDF	link	link
94/25/EEC	Recreational Crafts Directive	PDF	link	link
93/15/EEC	Explosives for Civil Use Directive	HTML	link	link
94/9/EEC	Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX)	PDF	link	link
90/384/EEC	Non-Automatic Weighing Instruments Directive	PDF	link	link
89/686/EEC	Personal Protective Equipment Directive (PPE)	PDF	link	link
89/106/EEC	Old Construction Products Directive (CPD)	PDF	link	link
88/378/EEC	Safety of Toys Directive (TSD)	PDF	link	link
2009/48/EC	Safety of Toys Directive (TSD) New	PDF	link	link
87/404/EEC	Simple Pressure Vessels Directive	PDF	link	link
2004/108/EC	Electromagnetic Compatibility Directive (EMC)	PDF	link	link
2006/95/EC	Low Voltage Equipment Directive (LVD)	PDF	link	link
GUIDANCE DOCUMENTS:	-	HTML
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	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. 6	PDF
MEDDEV	Guidelines on Medical Devices A guide for Manufacturers and Notified Bodies	PDF
MEDDEV	Guidelines On A Medical Devices Vigilance System Rev. 7	PDF
-	Draft Commission Regulation on electronic instructions for use of medical devices	PDF