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Obelis European Authorized Representative Center


"CE Marking Consultants with a Reputation for Excellence"



Obelis News:
CE Marking 93/68/EEC MDD 93/42/EEC - Medical Device Directive AIMDD 90/385/EEC - Active Implantable Medical Devices Directive IVDD 98/79/EC - In-Vitro Diagnostic Device Directive Cosmetics Directive 76/768/EEC EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive LVD 2006/95/EC - Low Voltage Directive R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive GPSD 2001/95/EC - General Product Safety Directive PPE 89/686/EEC - Personal Protective Equipment Directive TSD 2009/48/EC - Toy Safety Directive CPR 305/2011/EU – Construction Products Regulation PED 97/23/EC - Pressure Equipment Directive MVD 2007/46/EC - Motor Vehicle Directive ATEX 94/9/EC Directive MSD 2006/42/EC - Machinery Safety Directive

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 »

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 »

TSD 2009/48/EC - Toy Safety Directive

The European Parliament and Council Directive 2009/48/EC on the safety of toys (“TSD” - Toy Safety Directive) was published on 30 June 2009 and entered into force on 20 July 2009 …

TSD 88/378/EEC & 2009/48/EC Services »

CPR 305/2011/EU – Construction Products Regulation

The Construction Products Regulation (CPR 305/2011/EU), published by the European Parliament on 9 March 2011, repeals the Construction Products Directive (CPD 89/106/EEC) and enacts stricter rules on the construction industry. …

CPR 305/2011/EU 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 »

MVD 2007/46/EC - Motor Vehicle Directive

The European Union (EU) is revising the framework for the approval of motor vehicles with a new Directive (2007/46/EC), which repeals and replaces Directive 70/156/EEC in order to have a clearer, …

MVD 2007/46/EC Services »

ATEX 94/9/EC Directive

The Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (ATEX) Directive 94/9/EC of 23 March 1994, provides the essential health and safety requirements – leaving to standards developed …

ATEX 94/9/EC Services »

MSD 2006/42/EC - Machinery Safety Directive

The revised Machinery Directive 2006/42/EC does not introduce any radical changes compared with the old Machinery Directive 98/37/EC but aims at consolidating the achievements of the Machinery Directive in terms of …

MSD 2006/42/EC Services »

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25th Anniversary




Obelis International Offices

Obelis International Offices (O.I.O.) - A network aimed at creating local Obelis Offices around the world offering European Authorized Representative (EC REP) services to local markets ... read more


Events & Exhibitions




OneLink OneSolution

Obelis is excited to announce the latest OneLink OneSolution advancement. While still retaining the core group of international compliance experts ... read more

Obelis European Authorized Representative Center (O.E.A.R.C.)

Obelis European Authorized Representative Center (O.E.A.R.C.) , established in Brussels, Belgium since 1988, provides European Authorized Representative (EC REP), "EU Responsible Person" & CE Marking advisory services to manufacturers worldwide (EU & Non-EU), all in accordance with European Directives & Regulations.

Our high quality compliance solutions, proven by our ISO 9001:2008 & ISO 13485:2003 certification, include Classification, identification of EU standards, Technical Documentation review, Authorized Representative & EU Responsible Person, Product Notification & Product Registration to national EU Authorities, Labeling Compliance, GMDN Code Verification, Free Sales Certificates, Trade Mark submissions and many more.

While still retaining a unique expertise on medical devices, in-vitro diagnosis medical devices & cosmetics, Our team of experts will assist you in introducing or maintaining your product(s) circulation within the EU Market and guide you through the regulatory maze of product safety and requirements also for machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, toys and other consumer goods.

Contact us today and let us help you meet your requirements.

CE Marking Explained

The European Commission describes the CE Marking as the “Passport to Europe” which allows manufacturers to freely circulate their products within the European market. The CE Marking Directive specifies the manner in which the CE Marking is to be used. Despite some assumptions, the marking is not a symbol of quality, …
Read more: CE Marking

EC REP Explained - Local Domains

- Obelis brings the European market closer to your business - Obelis European Authorized Representative Center (O.E.A.R.C.) objective, to support non-European manufacturers and other market players understand and as such achieve conformity with European Directives & Regulations, has always been a primary one, as only conformity shall provide access to the …
Read more: International Markets

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