We are Obelis.
Obelis Group is a leading specialist in European regulatory, directive, and compliance strategy. Its comprehensive CE marking, responsible person, authorized representative, and consultancy services have helped countless European and non-European manufacturers alike introduce their products successfully to the EU market in full compliance with all regulatory standards and requirements.
Founded in 1998, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe. It is also a veteran member of the EAAR (European Association of Authorized Representatives) and a founding member of the ERPA (European Cosmetics Responsible Person Association).
Its specialization in the last 30 years has been crucial in proliferating safe, harmonized standards and compliance in the European community, shepherding countless quality products onto the EU market in full regulatory compliance.
Full European Compliance
Obelis’ services and expertise covers a majority of the New Approach European Directives (those making CE marking or an authorized representative mandatory for a product). Through its extensive work in the area, Obelis has become a market expert in CE marking and regulatory compliance for machinery, personal protective equipment, pressure equipment, radio and telecommunications equipment, electrical equipment, low voltage equipment, and toys, with a strong emphasis on cosmetics and medical and in-vitro devices.
Medical & In-Vitro Devices
As an EU leader in healthcare device regulation, Obelis offers full authorized representative services as well as consultancy and guidance on: technical file creation and review, market notification and vigilance, product classification, sales certification, identification of standards and essential requirements, risk management, CE marking, clinical evidence, and trade mark submissions. Obelis’ regularly updated platform for EU MDR and IVDR information, MDLaw.eu, is a key resource for all industry bodies, from manufactures to third-party distributors.
Cosmetics
Similarly, Obelis’ activity in the European cosmetics industry runs deep, allowing it to offer quality European responsible person services including: file verification, testing guidance, labelling review, product market notification, cosmeto-vigilance, market updates and consultancy, claim research and validation, nano-material notification, sales certification, and team training on key compliance areas.
