Updated version of the EU “Blue Guide” published!
News

On the 5th April 2016, the European Commission published an updated version of “The Blue Guide on the Implementation of EU Product Rules”. The document, commonly referred to as the “Blue Guide [...]

European Commission Publishes New Guidelines on PPE Directive
News

On 19 October 2015, the European Commission published new Guidelines on the application of Personal Protective Equipment Directive 89/686/EEC (PPE Directive). (more…) [...]

Common Approach on the Medical Devices Legislative Package
News

On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step [...]

Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
News

After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DE [...]

Services

Obelis Services

in Services

Obelis European Authorized Representative Center provides ISO certified services for the successful introduction of your products within the European territory in accordance to the European regulation.

Those services include, but are not limited to European Authorized Representative services (EC Rep), pre-market notification, post market advisory services, pre-CE marking services, Free Sales Certificate services, certificate of CE registration, and GMDN code research services.

Our services are backed by over 25 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

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European Authorized Representative Services

in Services

Our professional European Authorized Representative services aim to ensure compliance with most of the New Approach Directives, directives requiring either a CE marking or authorized representative,  such as machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, toys and other consumer goods.

Those services include, but are not limited to: 

  • Authorized Representative (31 EEA countries)
  • Registered Address in Europe
  • Technical File documentation review
  • Technical documentation keeping and updating
  • Labeling compliance and language requirements 
  • Incident reporting and complaint handling 

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Advisory services

in Services

Obelis aims to provide you full solutions for the introduction of your medical devices in the European market. Among others, our team of experts will guide you on: 

  • Permitted claims and regulatory advice
  • QMS implementation
  • Product safety consultancy
  • Product testing and certification services
  • Identification of proper regulation
  • Identification of EU harmonized standards
  • Post market surveillance assistance
  • Regulatory advice and updates

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Pre-CE marking Services

in Services

The basis for the compliance process lays on the correct classification of your product and selecting a notified body is just as important. Our pre-CE marking services include but are not limited to: 

  • Classification and Identification of proper regulation 
  • Classification of Borderline products
  • Guidance on Notified Body selection
  • Coordination between the manufacturer and the notified body

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Extra Services

in Services, Uncategorized

Additionally, we also provide the following services:

  • EU Harmonized Standards
  • Free Sales Certificate services
  • Certificate of CE Registration 
  • GMDN Code Research 
  • Labeling translation 
  • Custom Clearance Code Verification
  • EU Trademark Submission 
  • EU Environmental Regulations
  • Agreement Consultancy and Review Services 

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Global Services

in Services

Our mission is to provide clients with the finest quality services and personalized solutions to the complex regulatory requirements worldwide. As such, we developed a wide range of solutions to provide you with support in over 20 markets worldwide. 

  • Access to International Network 
  • Regulatory Solutions
  • International representation

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