Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"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 | |||
| 93/68/EEC | CE Marking Directive | |||
| 2001/95/EC | GPSD Directive | link | link | |
| 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 | |||
| 93/42/EEC | Medical Devices Directive (MDD) | link | link | |
| 2007/47/EC | Amendment to 90/385/EEC, 93/42/EEC & 98/8/EC | |||
| 98/79/EEC | In-Vitro Diagnostic Directive (IVDD) | link | link | |
| 90/385/EEC & 2007/47/EC | Active Implantable Medical Device Directive Consolidated Version | link | ||
| 90/385/EEC | Active Implantable Medical Devices Directive | link | link | |
| 76/768/EEC | Cosmetics Products Directive | link | ||
| 1223/2009/EC | Cosmetic Regulation NEW | link | ||
| 97/23/EC | Pressure Equipment Directive (PED) | link | link | |
| 95/16/EC | Lifts Directive | link | link | |
| 2006/42/EC | Safety of Machinery and Amendments to the Lifts Directive | link | link | |
| 1999/5/EC | Radio and Telecommunications Terminal Equipment Directive (R&TTE) | link | link | |
| 2000/9/EC | Cableway Installations Designed to Carry Persons Directive | link | link | |
| 94/25/EEC | Recreational Crafts Directive | 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) | link | link | |
| 90/384/EEC | Non-Automatic Weighing Instruments Directive | link | link | |
| 89/686/EEC | Personal Protective Equipment Directive (PPE) | link | link | |
| 89/106/EEC | Construction Products Directive (CPD) | link | link | |
| 88/378/EEC | Safety of Toys Directive (TSD) | link | link | |
| 2009/48/EC | Safety of Toys Directive (TSD) New | link | link | |
| 87/404/EEC | Simple Pressure Vessels Directive | link | link | |
| 2004/108/EC | Electromagnetic Compatibility Directive (EMC) | link | link | |
| 2006/95/EC | Low Voltage Equipment Directive (LVD) | link | link | |
| GUIDANCE DOCUMENTS: | - | HTML | ||
| MEDDEV | Guidelines for the classification of Medical Devices | |||
| - | Guide to the Implementation of Directives Based on the New Approach and the Global Approach | |||
| MEDDEV | CERTIF 2005–16 Rev. 2: Elements for a Horizontal Legislative Approach to Technical Harmonizati | |||
| MEDDEV | Supply of Instructions for use for IVD Medical Devices | |||
| MEDDEV | Guidelines on a Medical Devices Vigilance System Rev. 6 |