Obelis Group
Business Consulting and ServicesBrussels, Belgium51-200 Employees
Obelis Group is a Brussels-based specialist in European regulatory, directive, and compliance strategy for products seeking to enter the EU market. It provides CE marking support, as well as authorized representative and responsible person services, alongside broader consultancy on regulatory compliance. The firm serves both European and non-European manufacturers, helping them navigate EU requirements to bring products to market. Founded in 1988, it operates as one of the largest regulatory and compliance centers in Europe. Its practice spans a wide range of New Approach directives with emphasis on cosmetics and medical and in-vitro devices, and it supports activities such as technical file review, market notification, risk management, and related regulatory services. In February 2026, it announced a partnership with Kogenebiotech Co., Ltd. to assist with an IVD Class A notification, illustrating ongoing collaboration with manufacturers expanding into the EU.