Obelis European Authorized Representative Center
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CE Marking 93/68/EEC
CE Marking Directive 93/68/EEC of July 22, 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery),
MDD 93/42/EEC - Medical Device Directive
MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive will become mandatory on March 21, 2010. The …
MDD 93/42/EEC Services »AIMDD 90/385/EEC - Active Implantable Medical Devices Directive
AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active implantable medical …
AIMDD 90/385/EEC Services »IVDD 98/79/EC - In-Vitro Diagnostic Device Directive
IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing …
IVDD 98/79/EC Services »Cosmetics Directive 76/768/EEC
The Cosmetics Directive 76/768/EEC was published on July 27, 1976. It allows cosmetic products in the European Economic Area to circulate freely and ensures their safety for use. A cosmetic product …
Cosmetic 76/768/EEC Services »MSD 98/37/EC - Machinery Safety Directive
MSD 98/37/EC (Machinery Safety Directive) of the European Parliament and of the Council of June 22, 1998 was published on January 1, 1993. It has been amended according to the 2006/42/EC. …
MSD 98/37/EC Services »EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive
EMC Directive 2004/108/EC (Electromagnetic Compatibility Directive) of the European Parliament and of the Council was published on December 31, 2004 in the Official Journal of the European Union, L 390/24, and …
EMC 2004/108/EC Services »LVD 2006/95/EC - Low Voltage Directive
LVD 2006/95/EC ( Low Voltage Directive) of the European Parliament and of the Council of December 12, 2006 on the harmonization of the laws of Member States relating to electrical equipment …
LVD 2006/95/EC Services »R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive
The R&TTE Directive 1999/5/EC (Radio and Telecommunications Terminal Equipment Directive) was published on March 9, 1999. It covers all apparatuses using the radio frequency spectrum and all equipment associated with public …
R&TTE 1995/5/EC Services »GPSD 2001/95/EC - General Product Safety Directive
The GPSD 2001/95/EC (General Product Safety Directive) was published on January 15, 2004. In order to place products in the European Economic Area, distributors and manufacturers must comply with this directive. …
GPSD 2001/95/EC Services »PPE 89/686/EEC - Personal Protective Equipment Directive
PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an …
PPE 89/686/EEC Services »CPD 89/106/EEC - Construction Products Directive
CPD 89/106/EEC (Construction Products Directive) was published on December 21, 1988 by the European Council on the approximation of laws, regulations and administrative provisions of the Member States. It was then …
CPD 89/106/EEC Services »PED 97/23/EC - Pressure Equipment Directive
PED 97/23/EC (Pressure Equipment Directive) adopted by the European Parliament and the European Council on May 29, 1997 was published on May 29, 2002. Previously, manufacturers of pressure equipment could decide …
PED 97/23/EC Services »TSD 88/378/EEC - Toy Safety Directive
TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 was published on January 1, 1990 on the approximation of the laws of the Member States concerning the safety …
TSD 88/378/EEC Services »
Obelis European Authorized Representative
Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives.
Our high quality compliance solutions, proven by our ISO 9001:2001 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters.
Our team of experts can assist you in introducing or maintaining your product(s) circulation within the EU and guide you through the regulatory maze of product safety and requirements.
Contact us today and let us help you meet your requirements.
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Recently Posted
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The Directive
The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the … -
Compliance with the AIMDD-90-385-EEC
Demonstrating compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following: Essential Requirements General requirements (” The devices … -
Scope of the AIMDD-90-385-EEC
Medical devices (as a whole) include any instrument, appliance, software, etc. used for the purpose of prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast … -
Structrure of the AIMDD-90-385-eec
The AIMDD 90/385/EEC amended by the 2007/47/EC consists of 17 Articles and 9 Annexes. These Articles define the attributes of a medical device which is … -
Compliance with the CE Marking Directive
The Manufacturer or Supplier should demonstrate that the product complies with the essential requirements, using one of the product conformity assessment modules available within the … -
Scope of the CE Marking Directive
The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE marking …
CE Marking Explained
The European Commission describes CE Marking as a “Passport to Europe” which allows manufacturers to freely circulate their products within the European market. CE Marking is now mandatory for a wide range of products sold within the European Union. Until 1985 the European Directives demanded specific and detailed requirements per product …
Read more: CE Marking
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