Services

GDPR Services

With over 30 years of expertise with EU Regulations, Obelis European Authorized Representative Center (O.E.A.R.C.) provides ISO certified services supporting companies in reference to the processing of personal data in accordance with the General Data Protection Regulation (GDPR) (EU) 2016/679.

The basis for compliance lies within the correct identification of the lawful bases for processing and the applicable legal framework. Our experts will support companies in the identification of the lawful basis for processing activities, provide guidance on privacy policy drafting and provide practical support in reference to the data subjects and Supervisory Authorities.

Those services include, but are not limited to:

  • GDPR Representative (Art 27)
  • Registered Address in the EU
  • GDPR documentation review
  • GDPR documentation keeping and updating
  • Compliance Certificates (GDPR Representative & Documentation Review)
  • Information request and complaint handling
  • Ongoing consultancy on EU Regulations
  • Regulatory News & Updates

Obelis 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.

European Authorized Representative 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

Advisory 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

Pre-CE marking 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

Extra Services

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

Global 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